FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×

13,237 results

8329–8352 of 13,237

Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry

Cleared Jul 06, 1987

LIQUICHEK PEDIATRIC CONTROL LEVELS I AND II

Chemistry · 27d

Cleared Jul 01, 1987

PFI-20 POLARIZING FLUORIMETER

The Perkin-Elmer Corp.

Chemistry · 70d

Cleared Jul 01, 1987

PHENYTOIN FPIA CONTROLS

Sigma Diagnostics, Inc.

Chemistry · 70d

Cleared Jul 01, 1987

EASY-TEST AMMONIA (AMON) ITEM NO. 16695

Em Diagnostic Systems, Inc.

Chemistry · 30d

Cleared Jul 01, 1987

IRMA-COUNT TSH RKTS1, RKTS2, RKTS5, RKTSX

Diagnostic Products Corp.

Chemistry · 23d

Cleared Jun 29, 1987

MODIFIED SALTEX REAGENT STRIPS

Miles Laboratories, Inc.

Chemistry · 160d

Cleared Jun 24, 1987

NOVA 13 SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER

Nova Biomedical Corp.

Chemistry · 16d

Cleared Jun 23, 1987

KODAK EKTACHEM 700XR ANALYZER

Eastman Kodak Company

Chemistry · 22d

Cleared Jun 22, 1987

TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT

Canadian Bioclinical, Ltd.

Chemistry · 104d

Cleared Jun 22, 1987

CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT

Canadian Bioclinical, Ltd.

Chemistry · 104d

Cleared Jun 22, 1987

ALKALINE PHOSPHATASE (AP) FOR CONT. FLOW INSTRU.

Chemistry · 63d

Cleared Jun 22, 1987

ULTRA-VIOLET BUN REAGENT KIT (RATE)

Biochemical Trade, Inc.

Chemistry · 63d

Cleared Jun 19, 1987

TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II

Hybritech, Inc.

Chemistry · 22d

Cleared Jun 17, 1987

DELFIA(TM) THYROXINE (T4) KIT

Lkb Instruments, Inc.

Chemistry · 77d

Cleared Jun 17, 1987

LIQUID TDM CONTROLS

Biological Industries

Chemistry · 42d

Cleared Jun 17, 1987

TECHNICON RA(R) SYSTEMS & ASSIST(R) CLIN. ANALYZER

Technicon Instruments Corp.

Chemistry · 33d

Cleared Jun 17, 1987

UNI-FAST CREATINE KINASE TEST (CK)

Chemistry · 22d

Cleared Jun 17, 1987

KODAK EKTACHEM 700S ANALYZER

Eastman Kodak Company

Chemistry · 16d

Cleared Jun 17, 1987

KODAK EKTACHEM 700P ANALYZER

Eastman Kodak Company

Chemistry · 16d

Cleared Jun 17, 1987

ABBOTT SPECTRUM BICARBONATE REAGENT KIT

Abbott Laboratories

Chemistry · 16d

Cleared Jun 17, 1987

TIPSEP-CORTISOL RIA DIAGNOSTIC KIT

Nuclear Diagnostics, Inc.

Chemistry · 9d

Cleared Jun 16, 1987

RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125]

Immunalysis Corporation

Chemistry · 63d

Cleared Jun 15, 1987

RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125]

Immunalysis Corporation

Chemistry · 48d

Cleared Jun 12, 1987

SIGMA'S CALCIUM PROCEDURE NO. 587

Sigma Diagnostics, Inc.

Chemistry · 81d