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

915 Pathology devices

726–750 of 915

Cleared Aug 03, 1984

K842728 · E K Ind., Inc.

IFP · Formalin, Neutral Buffered · 21d

Cleared Aug 03, 1984

K842730 · E K Ind., Inc.

ICF · Crystal Violet For Histology · 21d

Cleared Aug 03, 1984

ZENKERS SOLUTION

K842732 · E K Ind., Inc.

IFH · Solution, Zenker's · 21d

Cleared Aug 03, 1984

WRIGHTS STAIN SOLUTION

K843051 · Reagent Laboratory, Inc.

Cleared Jul 27, 1984

K842583 · Viromed Laboratories, Inc.

KIR · Cells, Animal And Human, Cultured · 24d

Cleared Jul 27, 1984

K842584 · Viromed Laboratories, Inc.

KIR · Cells, Animal And Human, Cultured · 24d

Cleared Jul 25, 1984

SAFRANIN, 1% W/V

K842920 · E K Ind., Inc.

Cleared Jul 20, 1984

BASAL MED. EAGLE B8265, W/EARLS SALTS

K842671 · Sigma Chemical Co.

KIT · Media And Components, Synthetic Cell And Tissue Culture · 10d

Cleared Jul 20, 1984

MINIMUM ESSENTIAL MED. M0769 W/WO

K842672 · Sigma Chemical Co.

KIT · Media And Components, Synthetic Cell And Tissue Culture · 10d

Cleared Jun 26, 1984

PARAPLAST EXTRA TISSUE EMBEDDING MED.

K842053 · Sherwood Medical Co.

KEO · Formulations, Paraffin, All · 35d

Cleared Jun 22, 1984

HANKS BALANCED SALTS-HBSS H2387

K842002 · Sigma Chemical Co.

KIT · Media And Components, Synthetic Cell And Tissue Culture · 37d

Cleared Jun 07, 1984

K841806 · Viromed Laboratories, Inc.

KIR · Cells, Animal And Human, Cultured · 37d

Cleared May 22, 1984

SCOTTS TAP WATER SUBSTITUTE 7

K841423 · Reagent Laboratory, Inc.

JCC · Ph Buffer · 47d

Cleared May 11, 1984

DULBECCO'S PHOSPHATE BUFFERED SALINE

K841744 · Sigma Chemical Co.

KIT · Media And Components, Synthetic Cell And Tissue Culture · 14d

Cleared May 07, 1984

RHESUS SV5/SV40

K841665 · Viromed Laboratories, Inc.

KIR · Cells, Animal And Human, Cultured · 14d

Cleared May 07, 1984

RABBIT KIDNEY CELLS

K841666 · Viromed Laboratories, Inc.

KIR · Cells, Animal And Human, Cultured · 14d

Cleared May 02, 1984

K841488 · Surgipath Medical Industries, Inc.

KDX · Solution, Decalcifier, Acid Containing · 22d

Cleared Mar 23, 1984

TISSUE CULTURE REFEEDING MEDIUM

K834113 · Bartels Immunodiagnostic Supplies, Inc.

KIT · Media And Components, Synthetic Cell And Tissue Culture · 115d

Cleared Mar 22, 1984

HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN

K834117 · Bartels Immunodiagnostic Supplies, Inc.

KIR · Cells, Animal And Human, Cultured · 114d

Cleared Mar 22, 1984

K834119 · Bartels Immunodiagnostic Supplies, Inc.

KIR · Cells, Animal And Human, Cultured · 114d

Cleared Mar 22, 1984

LLC-MK2-RHESUS MONKEY KIDNEY CELLS

K834120 · Bartels Immunodiagnostic Supplies, Inc.

KIR · Cells, Animal And Human, Cultured · 114d

Cleared Mar 22, 1984

WI-38 HUMAN LUNG CELLS

K834123 · Bartels Immunodiagnostic Supplies, Inc.

KIR · Cells, Animal And Human, Cultured · 114d

Cleared Mar 22, 1984

K834124 · Bartels Immunodiagnostic Supplies, Inc.

KIR · Cells, Animal And Human, Cultured · 114d

Cleared Mar 22, 1984

K834126 · Bartels Immunodiagnostic Supplies, Inc.

KIR · Cells, Animal And Human, Cultured · 114d

Cleared Mar 22, 1984

PBS W/MG+2 & CA+2

K834136 · Bartels Immunodiagnostic Supplies, Inc.

KIT · Media And Components, Synthetic Cell And Tissue Culture · 113d

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