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
4489–4512 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 16, 1997
ALP REAGENT SET
K971463 · CJE
Carolina Liquid Chemistries Corp.
Chemistry · 25d
Cleared May 16, 1997
TOTAL PROTEIN OR TP
K971524 · CEK
Carolina Liquid Chemistries Corp.
Chemistry · 18d
Cleared May 12, 1997
SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM
K970556 · CGA
Lifescan, Inc.
Chemistry · 88d
Cleared May 12, 1997
GREINER VACUETTE BLOOD COLLECTION TUBE
K971239 · JKA
Greiner America, Inc.
Chemistry · 40d
Cleared May 12, 1997
DSL ACTIVE NON-EXTRACTION IGF-I ELISA
K971353 · CFL
Diagnostic Systems Laboratories, Inc.
Chemistry · 31d
Cleared May 09, 1997
WINMAX SOFTWARE SYSTEMS
K965103 · JJF
Diagnostic Products Corp.
Chemistry · 140d
Cleared May 09, 1997
STAT PROFILE ULTRA M ANALYZER
K970710 · CHL
Nova Biomedical Corp.
Chemistry · 72d
Cleared May 08, 1997
EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST
K971286 · LCX
Excel Scientific, Inc.
Chemistry · 31d
Cleared May 07, 1997
LACTATE DEHYDROGENASE (LD)
K970684 · CFJ
Randox Laboratories, Ltd.
Chemistry · 72d
Cleared May 07, 1997
WAKO DIRECT BILIRUBIN V
K970986 · CIG
Wako Chemicals USA, Inc.
Chemistry · 50d
Cleared May 06, 1997
SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT)
K971466 · JQB
Carolina Liquid Chemistries Corp.
Chemistry · 14d
Cleared May 02, 1997
GREINER VACUETTE BLOOD COLLECTION TUBE
K971221 · GIM
Greiner America, Inc.
Chemistry · 30d
Cleared May 02, 1997
LD-L REAGENT
K971398 · CFJ
Carolina Liquid Chemistries Corp.
Chemistry · 17d
Cleared May 02, 1997
ALB OR ALBUMIN
K971445 · CIX
Carolina Liquid Chemistries Corp.
Chemistry · 11d
Cleared Apr 28, 1997
FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM
K971141 · CEC
Dade Chemistry Systems, Inc.
Chemistry · 31d
Cleared Apr 25, 1997
ACCULINE PREGNANCY TEST
K971122 · JHI
Genix Biotek, Inc.
Chemistry · 29d
Cleared Apr 23, 1997
PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT
K964756 · JFH
Wano-Tech Corp.
Chemistry · 147d
Cleared Apr 23, 1997
LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS
K971014 · JJX
Lifescan, Inc.
Chemistry · 34d
Cleared Apr 23, 1997
LIQUID LIGAND 1,2,3
K971071 · JJY
Chiron Diagnostics Corp.
Chemistry · 30d
Cleared Apr 21, 1997
SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS
K970314 · MSJ
Beckman Instruments, Inc.
Chemistry · 87d
Cleared Apr 21, 1997
MINI SAMPLER PROCESSOR
K970616 · JQW
Cavro Scientific Instruments, Inc.
Chemistry · 62d
Cleared Apr 21, 1997
LIQUID GLUCOSE (OXIDASE) REAGENT SET
K970781 · CGA
Pointe Scientific, Inc.,
Chemistry · 48d
Cleared Apr 21, 1997
URIC ACID REAGENT
K970867 · KNK
Derma Media Lab., Inc.
Chemistry · 42d
Cleared Apr 21, 1997
WAKO TOTAL BILIRUBIN V
K970985 · JFM
Wako Chemicals USA, Inc.
Chemistry · 34d