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
7753–7776 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 09, 1988
STAT FAX(TM)
K882938 · JJQ
Awareness Technology, Inc.
Chemistry · 58d
Cleared Sep 09, 1988
BLOOD GAS MIXTURE
K882941 · CHL
Swisco, Inc.
Chemistry · 64d
Cleared Sep 09, 1988
A.QC CHEMISTRY CONTROL LEVEL 2
K883012 · JJY
Arden Medical Systems, Inc.
Chemistry · 52d
Cleared Sep 09, 1988
T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS
K883085 · KHQ
Serono Diagnostics, Inc.
Chemistry · 49d
Cleared Sep 09, 1988
ALTLTS ALANINE AMINO TRANSFERASE ALT
K883205 · CKA
Electro-Nucleonics, Inc.
Chemistry · 43d
Cleared Sep 09, 1988
LACTATE DEHYDROGENASE LDH
K883206 · CFJ
Electro-Nucleonics, Inc.
Chemistry · 43d
Cleared Sep 09, 1988
PHASE II FSH KIT
K883279 · CGJ
Vitek Systems, Inc.
Chemistry · 37d
Cleared Sep 08, 1988
OLYMPUS REPLY CHEMISTRY ANALYZER
K882451 · JJE
Olympus Corp.
Chemistry · 86d
Cleared Sep 07, 1988
MICROLYTE 7
K880973 · JFP
The Rupp & Bowman Co.
Chemistry · 183d
Cleared Sep 02, 1988
MULTI-CHEMISTRY LINEARITY STANDARD
K875285 · JIX
Verichem Laboratories, Inc.
Chemistry · 248d
Cleared Sep 02, 1988
RFA-300 RAPID FLOW ANALYZER W/COMPUTER
K883020 · JJF
Alpkem Corp.
Chemistry · 45d
Cleared Aug 30, 1988
DC-LIQUICAL CATALOGUE #SE-030
K882258 · JIX
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 91d
Cleared Aug 30, 1988
ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES
K882741 · CKG
Nichols Institute Diagnostics
Chemistry · 60d
Cleared Aug 30, 1988
FIAGEN HGH FLUOROIMMUNOASSAY KIT
K882823 · CFL
Cyberfluor, Inc.
Chemistry · 53d
Cleared Aug 30, 1988
DTR ANALYZER
K882913 · JJE
Abbott Laboratories
Chemistry · 49d
Cleared Aug 30, 1988
VISTA INSTRUMENT
K882914 · JJE
Abbott Laboratories
Chemistry · 49d
Cleared Aug 30, 1988
DART CARBON DIOXIDE
K883055 · KHS
Coulter Electronics, Inc.
Chemistry · 42d
Cleared Aug 30, 1988
WAKO(TM) AUTOKIT AMYLASE
K883059 · CJA
Wako Chemicals USA, Inc.
Chemistry · 42d
Cleared Aug 29, 1988
FIRSTDAY(TM) EARLY PREGNANCY TESTING KIT
K881015 · JHI
Pacific Biotech, Inc.
Chemistry · 172d
Cleared Aug 29, 1988
LAD MODEL 633 LUMINOMETER
K882608 · JJQ
Los Alamos Diagnostics
Chemistry · 66d
Cleared Aug 29, 1988
RAICHEM(TM) BILIRUBIN STANDARD
K882726 · JIS
Reagents Applications, Inc.
Chemistry · 59d
Cleared Aug 29, 1988
DADE(R) CK-MB IMMUNOASSAY CONTROL
K882795 · JJT
Baxter Healthcare Corp
Chemistry · 54d
Cleared Aug 29, 1988
RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN.
K882801 · JGS
Hf Scientific, Inc.
Chemistry · 53d
Cleared Aug 23, 1988
MD STRIPS BG
K875049 · CGA
Amatech International, Inc.
Chemistry · 258d