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
7417–7440 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 09, 1989
SR1 (FSH) IMMUNOENZYMETRIC ASSAY
K892706 · CGJ
Serono-Baker Diagnostics, Inc.
Chemistry · 56d
Cleared Jun 09, 1989
REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181
K893223 · JHO
Helena Laboratories
Chemistry · 43d
Cleared Jun 07, 1989
CLA 200 CHEMPRO(R) LIPID ANALYZER
K892238 · CHH
Johnson & Johnson Professionals, Inc.
Chemistry · 64d
Cleared Jun 07, 1989
EASY-TEST IRON (IRON) ITEM NO. 16686
K892863 · JIY
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared May 24, 1989
HCG IRMA II
K891770 · JHI
Pacific Biotech, Inc.
Chemistry · 61d
Cleared May 24, 1989
AMRESCO URIC ACID REAGENTS #7628
K892395 · KNK
American Research Products Co.
Chemistry · 47d
Cleared May 22, 1989
COOMASSIE BLUE TOTAL PROTEIN ASSAY KIT
K890618 · CEK
Kenlor Industries, Inc.
Chemistry · 104d
Cleared May 22, 1989
ROCHE(R) CARDIOSCREEN-CK
K891462 · CGS
Roche Diagnostic Systems, Inc.
Chemistry · 68d
Cleared May 22, 1989
AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT
K891468 · CIT
Trace Scientific , Ltd.
Chemistry · 68d
Cleared May 22, 1989
YSI MODEL 2300 STAT GLUCOSE AND L-LACTATE ANALYZER
K891480 · CGA
Yellow Springs Instrument Co., Inc.
Chemistry · 66d
Cleared May 22, 1989
AVL MODEL 987 ELECTROLYTE ANALYZER
K891578 · CHL
Avl Scientific Corp.
Chemistry · 63d
Cleared May 22, 1989
DRI-DYE CHECK STRIPS (TM)-405
K892656 · JJX
Awareness Technology, Inc.
Chemistry · 39d
Cleared May 22, 1989
T4 CLASP-BEAD EIA KIT
K892853 · KLI
Biotecx Laboratories, Inc.
Chemistry · 34d
Cleared May 16, 1989
PH BLOOD GAS CONTROL PRODUCTS
K884266 · JPK
Alko Diagnostic Corp.
Chemistry · 217d
Cleared May 16, 1989
GDS ENZYMATIC THEOPHYLLINE REAGENT
K891761 · LCY
Gds Diagnostics
Chemistry · 53d
Cleared May 16, 1989
TDX BARBITURATES SERUM
K892650 · DIS
Abbott Laboratories
Chemistry · 34d
Cleared May 11, 1989
THERMOMAX MICROPLATE READER, MODIFICATION
K892063 · JJQ
Molecular Devices Corp.
Chemistry · 42d
Cleared May 10, 1989
DIRECT BILIRUBIN FOR CONTINUOUS FLOW
K891240 · CIG
Catachem, Inc.
Chemistry · 64d
Cleared May 09, 1989
HI CHEM CREATININE REAGENT (PRODUCT #88809)
K890671 · CGX
Hichem Diagnostics
Chemistry · 89d
Cleared May 09, 1989
CK-NAC 2-VIAL REAGENT W/SUBSTRATE START
K891470 · CGS
Trace Scientific , Ltd.
Chemistry · 55d
Cleared May 09, 1989
CLS 962 MICROPLATE PHOTOMETER
K891869 · JJQ
Cambridge Life Sciences Plc.
Chemistry · 43d
Cleared May 05, 1989
LD1 ISOENZYME REAGENT KIT
K890996 · JGF
Trace Scientific , Ltd.
Chemistry · 67d
Cleared May 05, 1989
IQ ALBUMIN
K891375 · CIX
Bd Becton Dickinson Vacutainer...
Chemistry · 57d
Cleared May 04, 1989
ELECTRODE A.PH BLOOD GAS B.ELECTROLYTE SYSTEMS
K884267 · CHL
Alko Diagnostic Corp.
Chemistry · 205d