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.

1105
Total
1082
Cleared
212d
Avg (2y)
1976
Since
639 Pathology devices
101–125 of 639
Cleared Mar 24, 1993
25 CM2, 75 CM2, 125 CM2 FLASK, CATALOG #03-291
K930390 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 57d
Cleared Mar 24, 1993
25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-261
K930391 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 57d
Cleared Mar 24, 1993
16 X 125 MM TEST TUBE, CATALOG #01-111
K930392 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 57d
Cleared Mar 24, 1993
ONE DRAM SHELL VIAL, CATALOG #02-261
K930393 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 57d
Cleared Mar 24, 1993
25 CM2, 75 CM2, A50 CM2 FLASK, CATALOG #03-211
K930394 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 57d
Cleared Mar 24, 1993
ONE DRAM SHELL VIAL, CATALOG #02-461
K930395 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 57d
Cleared Mar 24, 1993
16 X 125 MM TEST TUBE, CATALOG #01-291
K930396 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 57d
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

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All categories 639 KIT Media And Components, Synthetic Cell And Tissue Culture 212 KIR Cells, Animal And Human, Cultured 65 KIS Sera, Animal And Human 20 PSY Whole Slide Imaging System 19 JTS Stains, Microbiologic 16 QKQ Digital Pathology Image Viewing And Management Software 13 HYJ Hematoxylin 8 IFP Formalin, Neutral Buffered 8 PZM Next Generation Sequencing Based Tumor Profiling Test 7 HZJ Stain, Papanicolau 7 KIP Formulations, Balanced Salt Solutions 7 KEO Formulations, Paraffin, All 7 IAF Wright's Stain 7 IEO Processor, Tissue, Automated 6 NQN Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity 6