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
8041–8064 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 21, 1988
WAKO(TM) PRETEST 5A
K873366 · CDM
Wako Chemicals USA, Inc.
Chemistry · 153d
Cleared Jan 21, 1988
A-GENT TRIGLLYCERIDES GPO
K874187 · CDT
Abbott Laboratories
Chemistry · 99d
Cleared Jan 21, 1988
LYPHOCHEK ASSAYED CHEMISTRY CONTROL (HUMAN), I/II
K874280 · JJY
Bio-Rad
Chemistry · 93d
Cleared Jan 21, 1988
SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM
K874284 · JHT
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 99d
Cleared Jan 21, 1988
STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY
K874438 · LEH
Baxter Healthcare Corp
Chemistry · 85d
Cleared Jan 21, 1988
KODAK EKTACHEM DT SLIDES (MG)
K874576 · JGJ
Eastman Kodak Company
Chemistry · 76d
Cleared Jan 21, 1988
KODAK EKTACHEM DT SLIDES (PHOS)
K874577 · CEO
Eastman Kodak Company
Chemistry · 76d
Cleared Jan 21, 1988
TRIGLYERIDES TEST KIT
K874584 · CDT
Ciba Corning Diagnostics Corp.
Chemistry · 73d
Cleared Jan 21, 1988
EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017
K874586 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 73d
Cleared Jan 21, 1988
EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010
K874600 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 73d
Cleared Jan 21, 1988
RAICHEM(TM) MAGNESIUM REAGENT
K874822 · JGJ
Reagents Applications, Inc.
Chemistry · 58d
Cleared Jan 21, 1988
PYRIDOXAL-5-PHOSPHATE TABLETS
K874835 · CKA
Boehringer Mannheim Corp.
Chemistry · 58d
Cleared Jan 21, 1988
QUANTIMETRIX URINE DIPSTICK CONTROL
K874890 · JJW
Quantimetrix Medical Industries
Chemistry · 51d
Cleared Jan 11, 1988
FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201
K874621 · CFT
Cyberfluor, Inc.
Chemistry · 62d
Cleared Jan 11, 1988
FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301
K874624 · CEP
Cyberfluor, Inc.
Chemistry · 62d
Cleared Jan 11, 1988
BILIRUBIN (TOTAL)
K875069 · CIG
Tech-Co, Inc.
Chemistry · 33d
Cleared Jan 11, 1988
ALBUMIN, BROMCRESOL GREEN DYE-BINDING
K875070 · CIX
Tech-Co, Inc.
Chemistry · 33d
Cleared Jan 07, 1988
REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM
K874809 · JJY
Biotrol, USA, Inc.
Chemistry · 48d
Cleared Jan 07, 1988
MULTICHEM HDL PRECIPITATING REAGENT #S0914
K874820 · LBR
Simmler, Inc.
Chemistry · 44d
Cleared Jan 05, 1988
URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC)
K873371 · CHQ
Bio-Rad
Chemistry · 137d
Cleared Jan 05, 1988
LUMICON
K873893 · JJQ
Hamilton Co.
Chemistry · 104d
Cleared Jan 05, 1988
REAGENT A AND REAGENT B
K874413 · JIX
Seradyn, Inc.
Chemistry · 69d
Cleared Jan 05, 1988
BLOOD UREA NITROGEN
K874532 · CDW
Catachem, Inc.
Chemistry · 63d
Cleared Jan 05, 1988
PARAMAX URINE/CSF CALIBRATOR
K874587 · JIX
Baxter Healthcare Corp
Chemistry · 57d