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
7849–7872 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 07, 1988
ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD)
K881173 · CIQ
Tech-Co, Inc.
Chemistry · 81d
Cleared Jun 07, 1988
DYNATECH SPD 2000, NUMBER 002-910-0000
K881195 · JQW
Dynatech Laboratories, Inc.
Chemistry · 78d
Cleared Jun 07, 1988
BUN (KINETIC)
K881677 · CDQ
Boehringer Mannheim Corp.
Chemistry · 49d
Cleared Jun 07, 1988
TERUMO SENSIBEAD EIA PROGESTERONE KIT
K881693 · JIS
Terumo Medical Corp.
Chemistry · 49d
Cleared Jun 07, 1988
TECHNICON CHEM 1(R) SYSTEM, DIRECT BILIRUBIN
K881798 · CIG
Technicon Instruments Corp.
Chemistry · 41d
Cleared Jun 02, 1988
VITALOGRAPH-EC60 HYDROGEN MONITOR
K874892 · NRH
Vitalograph , Ltd.
Chemistry · 184d
Cleared Jun 02, 1988
SODIUM/POTASSIUM SERUM RANGE LINEARITY STANDARDS
K881436 · JJY
Hichem Diagnostics
Chemistry · 58d
Cleared Jun 01, 1988
RIA-QUICK
K881194 · JQP
Quantitative Technologies, Inc.
Chemistry · 72d
Cleared Jun 01, 1988
IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225
K881351 · JHY
Intl. Immunoassay Laboratories, Inc.
Chemistry · 63d
Cleared Jun 01, 1988
VISION(R) LDH (LACTATE DEHYDROGENASE)
K881474 · CFJ
Abbott Laboratories
Chemistry · 55d
Cleared Jun 01, 1988
SYNCHRON CX(TM)5 CLINICAL ANALYZER
K881495 · JJE
Beckman Instruments, Inc.
Chemistry · 54d
Cleared Jun 01, 1988
SYNCHRON CX(TM)4 CLINICAL ANALYZER
K881498 · JJE
Beckman Instruments, Inc.
Chemistry · 54d
Cleared Jun 01, 1988
REP LIPO KIT CAT. NO 3180
K881809 · JHO
Helena Laboratories
Chemistry · 34d
Cleared May 31, 1988
URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C
K880584 · CDM
Mach Diag. C/O Wichita State University
Chemistry · 111d
Cleared May 31, 1988
GAMMA GLUTAMYL TRANSFERASE REAGENT SET
K881239 · JPZ
Tech-Neal Scientific, Inc.
Chemistry · 70d
Cleared May 31, 1988
UVMAX KINETIC MICROPLATE READER
K881803 · JJQ
Molecular Devices Corp.
Chemistry · 33d
Cleared May 27, 1988
LIPASE UV [TOYO]
K874027 · CHI
Advocacy International, Ltd.
Chemistry · 238d
Cleared May 27, 1988
ABBOTT BREATH ACETONE ANALYZER
K875029 · JIN
Abbott Laboratories
Chemistry · 172d
Cleared May 27, 1988
DART PHENYTOIN
K880294 · LFO
Coulter Electronics, Inc.
Chemistry · 123d
Cleared May 27, 1988
CALCIUM
K880308 · CIC
Catachem, Inc.
Chemistry · 123d
Cleared May 27, 1988
MULTI-FUNCTION BLOOD GAS CONTROL
K880447 · JJY
Bionostics, Inc.
Chemistry · 115d
Cleared May 27, 1988
ASPARTATE AMINOTRANSFERASE ASSAY KIT (IFCC)
K880692 · CIT
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 95d
Cleared May 27, 1988
RAICHEM(TM) MAGNESIUM REAGENT, ENZYMATIC
K880880 · JGJ
Reagents Applications, Inc.
Chemistry · 86d
Cleared May 27, 1988
LYTENING 5
K880917 · JGS
Amdev, Inc.
Chemistry · 85d