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
4753–4776 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 27, 1996
ELECYS CALCHECK T 3
K963167 · JJX
Boehringer Mannheim Corp.
Chemistry · 13d
Cleared Aug 27, 1996
ELECSYS CALCHECK T4
K963178 · JJX
Boehringer Mannheim Corp.
Chemistry · 13d
Cleared Aug 23, 1996
HEMOCUE B-GLUCOSE SYSTEM
K961311 · LFR
Hemocue, Inc.
Chemistry · 141d
Cleared Aug 23, 1996
OPUS HLH
K962866 · CEP
Behring Diagnostics, Inc.
Chemistry · 31d
Cleared Aug 23, 1996
ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA
K962875 · CGI
Diagnostic Systems Laboratories, Inc.
Chemistry · 30d
Cleared Aug 23, 1996
SCRIPPS LABORATORIES HCG ONE-STEP
K962906 · JHI
Scripps Laboratories, Inc.
Chemistry · 29d
Cleared Aug 23, 1996
NOVA CHEMISTRY CONTROLS, LEVEL 1,2,AND 3 W/O CREAT
K962982 · JJY
Nova Biomedical Corp.
Chemistry · 22d
Cleared Aug 23, 1996
NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)
K963005 · JFL
Nova Biomedical Corp.
Chemistry · 21d
Cleared Aug 23, 1996
ELECSYS CALCHECK TROPONIN T
K963143 · JJX
Boehringer Mannheim Corp.
Chemistry · 10d
Cleared Aug 23, 1996
ELECSYS CALCHECK TSH
K963147 · JJX
Boehringer Mannheim Corp.
Chemistry · 10d
Cleared Aug 23, 1996
ELECSYS CALCHECK CK-MB
K963182 · JJX
Boehringer Mannheim Corp.
Chemistry · 9d
Cleared Aug 21, 1996
BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS
K961792 · DHA
Biocircuits Corp.
Chemistry · 104d
Cleared Aug 21, 1996
IMMAGE IMMUNOCHEMISTRY SYSTEM
K962294 · JQX
Beckman Instruments, Inc.
Chemistry · 68d
Cleared Aug 20, 1996
LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III
K963085 · JJX
International Enzymes, Inc.
Chemistry · 12d
Cleared Aug 20, 1996
UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY
K963116 · JMO
Diagnostic Chemicals , Ltd.
Chemistry · 8d
Cleared Aug 19, 1996
TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
K961573 · CIN
Hybritech, Inc.
Chemistry · 118d
Cleared Aug 19, 1996
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
K962186 · LBR
Genzyme Corp.
Chemistry · 74d
Cleared Aug 16, 1996
SAFESTRIP
K955107 · CGA
Firehouse Medical, Inc.
Chemistry · 282d
Cleared Aug 16, 1996
RADIAS PHENYLALANINE TEST
K960437 · JNB
Bio-Rad
Chemistry · 198d
Cleared Aug 16, 1996
TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60
K961281 · CDT
Diagnostic Chemicals , Ltd.
Chemistry · 135d
Cleared Aug 16, 1996
MICROLAB 4000, MICROLAB 4200
K961896 · JQW
Hamilton Co.
Chemistry · 92d
Cleared Aug 16, 1996
SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR
K962762 · JJJ
Biotraces, Inc.
Chemistry · 31d
Cleared Aug 16, 1996
ACTIVE ANDROSTENEDIONE EIA
K963002 · CIZ
Diagnostic Systems Laboratories, Inc.
Chemistry · 14d
Cleared Aug 15, 1996
HICHEM CK/NAC REAGENT KIT
K962247 · CGS
Elan Pharma, Inc.
Chemistry · 65d