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
7993–8016 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 01, 1988
ALT (SGPT) REAGENT SET
K880275 · CKA
Tech-Neal Scientific, Inc.
Chemistry · 40d
Cleared Mar 01, 1988
WAKO(TM) AUTOKIT CHOLESTEROL
K880311 · CHH
Wako Chemicals USA, Inc.
Chemistry · 36d
Cleared Mar 01, 1988
IQ ALKALINE PHOSPHATASE
K880344 · CJK
Bd Becton Dickinson Vacutainer...
Chemistry · 35d
Cleared Feb 25, 1988
EASY-TEST POTASSIUM K ITEM NUMBER 19XXX
K880339 · CEJ
Em Diagnostic Systems, Inc.
Chemistry · 30d
Cleared Feb 24, 1988
KODAK EKTACHEM DT SLIDES (LIPA)
K875173 · CHI
Eastman Kodak Company
Chemistry · 69d
Cleared Feb 24, 1988
KODAK EKTACHEM DT SLIDES (CRSC)
K875191 · JFY
Eastman Kodak Company
Chemistry · 69d
Cleared Feb 24, 1988
KODAK EKTACHEM DT SLIDES (CKMB)
K875192 · JHY
Eastman Kodak Company
Chemistry · 69d
Cleared Feb 24, 1988
BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS
K875248 · JMT
Bioscan Instruments, Inc.
Chemistry · 64d
Cleared Feb 24, 1988
AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 6665
K880039 · JJX
Sigma Diagnostics, Inc.
Chemistry · 50d
Cleared Feb 18, 1988
DSL ACTIVE ESTRADIOL RIA (DSL #4300)
K873550 · CHP
Diagnostic Systems Laboratories, Inc.
Chemistry · 171d
Cleared Feb 18, 1988
AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144
K874362 · KHQ
Amersham Corp.
Chemistry · 118d
Cleared Feb 18, 1988
LYPHOCHEK WHOLE BLOOD CONTROL
K874731 · JJY
Bio-Rad
Chemistry · 92d
Cleared Feb 18, 1988
ASPARTATE AMINOTRANSFERASE AST/SGOT
K875071 · CIT
Tech-Co, Inc.
Chemistry · 71d
Cleared Feb 18, 1988
HDL CHOLESTEROL PRECIPITATING REAGENT
K880176 · LBR
Tech-Co, Inc.
Chemistry · 34d
Cleared Feb 18, 1988
CREATINE KINASE (COLORIMETRIC METHOD)
K880178 · JHY
Tech-Co, Inc.
Chemistry · 34d
Cleared Feb 18, 1988
MULTI-ENZYME LINEARITY SOLUTION
K880266 · JJT
Verichem Laboratories, Inc.
Chemistry · 27d
Cleared Feb 16, 1988
FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101
K874623 · CDX
Cyberfluor, Inc.
Chemistry · 98d
Cleared Feb 16, 1988
TECHNICON SMAC 3 SYSTEM
K875105 · JJC
Technicon Instruments Corp.
Chemistry · 64d
Cleared Feb 11, 1988
WAKO(TM) PRETEST 6A
K873409 · KHE
Wako Chemicals USA, Inc.
Chemistry · 170d
Cleared Feb 11, 1988
CALCIUM ASSAY KIT, NUMBER 120-19
K874496 · CIC
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 101d
Cleared Feb 11, 1988
COAT-A-COUNT NEONATAL 17-ALPHA HYDROXPROG RIA KIT
K874782 · JLX
Diagnostic Products Corp.
Chemistry · 84d
Cleared Feb 11, 1988
NOVA STAT PROFILE 5 ANALYZER + QUALITY CONTROL
K874832 · JGS
Nova Biomedical Corp.
Chemistry · 79d
Cleared Feb 11, 1988
T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE
K874866 · KLI
Serono Diagnostics, Inc.
Chemistry · 76d
Cleared Feb 11, 1988
MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)
K874903 · JPZ
Simmler, Inc.
Chemistry · 72d