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
9817–9840 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 15, 1984
ACTH NORMAL RANGE
K842249 · CKG
Diagnostic Systems Laboratories, Inc.
Chemistry · 70d
Cleared Aug 15, 1984
TDX REA CHOLESTEROL
K842320 · CHH
Abbott Laboratories
Chemistry · 64d
Cleared Aug 15, 1984
WAKO LDH CII TEST
K842452 · CFH
Wako Chemicals USA, Inc.
Chemistry · 54d
Cleared Aug 14, 1984
MED. 199 CATALOG M3769 W/EARLE'S SALT
K843043 · KIT
Sigma Chemical Co.
Chemistry · 12d
Cleared Aug 14, 1984
MINIM. ESSENTIAL MED. EAGLE M4144 W/
K843044 · KIT
Sigma Chemical Co.
Chemistry · 12d
Cleared Aug 12, 1984
TOYO JOZO URIC ACID TEST
K842103 · KNK
Advocacy International, Ltd.
Chemistry · 79d
Cleared Aug 12, 1984
SIGMA 58-UV ASPARTATE AMINOTRANSFERAS
K842411 · CIT
Sigma Chemical Co.
Chemistry · 54d
Cleared Aug 12, 1984
AST/GOT REAGENT SET UV RATE
K842521 · CIT
Sterling Biochemical, Inc.
Chemistry · 46d
Cleared Aug 12, 1984
IMMPULSE CORTISOL ASSAY REAGENTS
K842554 · CGR
Aktis Corp.
Chemistry · 41d
Cleared Aug 12, 1984
SIGMA 59-UV FOR ALANINE AMINOTRANSFER
K842564 · CKA
Sigma Chemical Co.
Chemistry · 41d
Cleared Aug 12, 1984
REPLACEMENT PARTS NOVA ELECTROLYTE ANAL
K842656 · JFL
Shaban Mfg. Co.
Chemistry · 33d
Cleared Aug 12, 1984
LACTALBUMIN HYDROLYSATE MED. CATALOG
K843045 · KIT
Sigma Chemical Co.
Chemistry · 10d
Cleared Aug 10, 1984
ESCHWEILER COMBI-ANALYSER MTA-500
K840961 · CEM
U.S. Science, Inc.
Chemistry · 157d
Cleared Aug 10, 1984
TOYO JOZO G-GTP TEST
K842104 · JPZ
Advocacy International, Ltd.
Chemistry · 77d
Cleared Aug 10, 1984
AMERLEX-M FREE T-4 RADIOIMMUNOASSAY KIT
K842482 · CEC
Amersham Corp.
Chemistry · 46d
Cleared Aug 10, 1984
OPTICLEAR
K842485 · JJN
Gelman Sciences, Inc.
Chemistry · 46d
Cleared Aug 10, 1984
OPTIPHOR-10
K842560 · JJN
Gelman Sciences, Inc.
Chemistry · 39d
Cleared Aug 10, 1984
SIMULTROPIN RADIOIMMUNOASSAY KIT LH
K842588
Bd Becton Dickinson Vacutainer...
Chemistry · 38d
Cleared Aug 10, 1984
AMER. BIO-SCIENCE LAB T3 REAGENTS
K842590 · CDP
American Bio-Science Laboratories
Chemistry · 38d
Cleared Aug 10, 1984
SULFOSALICYLIC ACID, 3% W/V
K842915 · JIQ
E K Ind., Inc.
Chemistry · 16d
Cleared Aug 07, 1984
SERUM IRON & SERUM IRON BINDING CAPACI
K842155 · CFM
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 69d
Cleared Aug 07, 1984
SERUM IRON & SERUM IRON BINDING CAPACITY
K842156 · CFM
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 69d
Cleared Aug 07, 1984
TDX REA IRON DIAGNOSTIC KIT
K842505 · CFM
Abbott Laboratories
Chemistry · 42d
Cleared Aug 07, 1984
DHEA-S DIRECT RIA KIT
K842555 · JKC
Biotecx Laboratories, Inc.
Chemistry · 36d