FDA Review Panel · PA

FDA 510(k) Pathology Devices

FDA 510(k) Pathology Devices - Regulatory Overview

FDA 510(k) pathology devices include instruments used in anatomical and clinical pathology laboratories. The FDA review panel code is PA.

Key categories:

  • Tissue staining systems - automated H&E, IHC and special stain platforms
  • Histology instruments - microtomes, tissue processors and embedding stations
  • Digital pathology - whole slide imaging (WSI) scanners and image analysis software
  • Cytology systems - liquid-based cytology and automated cell screening

Most pathology devices are Class I or Class II under 21 CFR Part 864. Data sourced from FDA 510(k) public files. Updated monthly.

1109
Total
1086
Cleared
214d
Avg (2y)
1976
Since
912 Pathology devices
276–300 of 912
Cleared Mar 24, 1993
16 X 125 MM TEST TUBE, CATALOG
K930397 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 57d
Cleared Mar 24, 1993
16 X 125 MM TEST TUBE, CATALOG #01-441
K930398 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 57d
Cleared Mar 23, 1993
CYTOQUANT(TM) MDCK CANINE KIDNEY CELLS
K930325 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 60d
Cleared Mar 23, 1993
ONE DRAM SHELL VIAL, CATALOG # 02-241
K930364 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
25CM2, 75CM2, 150CM2 FLASK, CATALOG #03-241
K930365 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
16 X 25 MM TEST TUBE, CATALOG #01-461
K930366 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
25CM2. 75CM2, 150 CM, FLASK, CATALOG #03-321
K930367 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
ONE DRAM SHELL VIAL, CATALOG #02-321
K930368 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
25CM, 75CM, 150CM, FLASK, CATALOG #03-311
K930369 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
ONE DRAM SHELL VIALS, CATALOG #02-311
K930370 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
16 X 125 MM TEST TUBE, CATALOG #01-321
K930371 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
16 X 125 MM TEST TUBE, CATALOG #01-311
K930372 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
ONE DRAM SHELL VIAL, CATALOG #02-111
K930373 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
25 CM2, 75 CM2, 150 CM2, FLASK, CATALOG #03-111
K930374 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
16 X 125 MM TEST TUBE, CATALOG #01-211
K930375 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
ONE DRAM SHELL VIAL, CATALOG #02-211
K930376 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-461
K930377 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-441
K930378 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
ONE DRAM SHELL VIAL, CATALOG #02-281
K930379 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
16 X 125 MM TEST TUBE, CATALOG #01-261
K930380 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
ONE DRAM SHELL VIAL, CATALOG #02-441
K930381 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
ONE DRAMSHELL VIAL, CATALOG #02-421
K930382 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-421
K930383 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-401
K930384 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
16 X 125 MM TEST TUBE, CATALOG #01-421
K930385 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d

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All categories 912 KIT Media And Components, Synthetic Cell And Tissue Culture 228 KIR Cells, Animal And Human, Cultured 123 JTS Stains, Microbiologic 27 PSY Whole Slide Imaging System 23 KIS Sera, Animal And Human 20 NQN Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity 15 QKQ Digital Pathology Image Viewing And Management Software 14 NOT 13 NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration 13 MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor 13 IAF Wright's Stain 12 MYA Immunohistochemistry Antibody Assay, Estrogen Receptor 12 IEO Processor, Tissue, Automated 11 NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection 10 NYI Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer 10