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
8257–8280 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 21, 1987
INNOTRON INNOFLUOR PHEYTOIN REAGENT SET
K872563 · LGR
Innotron of Oregon, Inc.
Chemistry · 58d
Cleared Aug 21, 1987
BIOTROL CHOLESTEROL ENZYMATIQUE COLOR
K872930 · CHH
Biotrol, USA, Inc.
Chemistry · 25d
Cleared Aug 19, 1987
TOTAL BILIRUBIN REAGENT - DMSO METHOD
K870364 · CIG
Trace Scientific , Ltd.
Chemistry · 203d
Cleared Aug 19, 1987
DIRECT BILIRUBIN REAGENT - ACID DIAZO METHOD
K870365 · CIG
Trace Scientific , Ltd.
Chemistry · 203d
Cleared Aug 19, 1987
CREATININE REAGENT - PICRIC ACID METHOD
K870366 · CGX
Trace Scientific , Ltd.
Chemistry · 203d
Cleared Aug 19, 1987
PHOSPHORUS REAGENT-DIRECT UV METHOD W/O REDUCTION
K870368 · CEO
Trace Scientific , Ltd.
Chemistry · 203d
Cleared Aug 19, 1987
CALCIUM REAGENT-METHYL THYMOL BLUE METHOD
K870369 · CIA
Trace Scientific , Ltd.
Chemistry · 203d
Cleared Aug 19, 1987
MAGNESIUM REAGENT - CALMAGITE METHOD
K870370 · JGJ
Trace Scientific , Ltd.
Chemistry · 203d
Cleared Aug 19, 1987
TOTAL PROTEIN REAGENT - BIURET METHOD
K870371 · CEK
Trace Scientific , Ltd.
Chemistry · 203d
Cleared Aug 19, 1987
ALBUMIN REAGENT - BROMCRESOL GREEN METHOD
K870372 · CIX
Trace Scientific , Ltd.
Chemistry · 203d
Cleared Aug 19, 1987
LB 9502 - CLINILUMAT, LB 952 - AUTO-CLINILUMAT
K872324 · JJQ
Berthold Analytical Instruments, Inc.
Chemistry · 63d
Cleared Aug 19, 1987
MODIFIED ALT (GPT) REAGENT
K872483 · CKA
Trace Scientific , Ltd.
Chemistry · 56d
Cleared Aug 19, 1987
MODIFIED ENZYMATIC BUN REAGENT
K872484 · CDQ
Trace Scientific , Ltd.
Chemistry · 56d
Cleared Aug 18, 1987
ABBOTT BIOTELL PREGNANCY TEST
K871996 · LCX
Abbott Laboratories
Chemistry · 84d
Cleared Aug 18, 1987
SYSTEM PACK FOR B.M.D/HITACHI 704 CHEM. ANA.(GABA)
K872306 · CIC
Boehringer Mannheim Corp.
Chemistry · 64d
Cleared Aug 17, 1987
IMMUBEAD THYROID UPTAKE
K872172 · KHQ
Immunotech Corp.
Chemistry · 70d
Cleared Aug 17, 1987
INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET
K872562 · LFW
Innotron of Oregon, Inc.
Chemistry · 54d
Cleared Aug 17, 1987
INNOFLUOR VANCOMYCIN REAGENT SET
K872579 · LEH
Innotron of Oregon, Inc.
Chemistry · 48d
Cleared Aug 17, 1987
TRIGLYCERIDE (UV) REAGENT
K872912 · JGW
Sigma Chemical Co.
Chemistry · 24d
Cleared Aug 13, 1987
ANALYST(TM) LIPID ROTOR & HDL CALIBRATOR/CONTROL
K871265 · LBS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 135d
Cleared Aug 13, 1987
NOVOCHECK/CHECKPOINT/CONTROL SOLUTION
K872049 · CGA
Garid, Inc.
Chemistry · 77d
Cleared Aug 13, 1987
TDXR FLECAINIDE
K872175 · LBZ
Abbott Laboratories
Chemistry · 66d
Cleared Aug 13, 1987
IMMUBEAD T3 ENZYME IMMUNOASSAY KIT
K872191 · CDP
Immunotech Corp.
Chemistry · 66d
Cleared Aug 13, 1987
IMMUBEAD T4 ENZYME IMMUNOASSAY KIT
K872192 · KLI
Immunotech Corp.
Chemistry · 66d