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
8209–8232 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 16, 1987
SPECTROPHOTOMETERS MODELS:ABC+,ABC,S 500, S 1000
K872749 · JJQ
Secomam Co.
Chemistry · 65d
Cleared Sep 16, 1987
LACTATE DEHYDROGENASE ISOENZYME 1
K872891 · CEX
Data Medical Associates, Inc.
Chemistry · 55d
Cleared Sep 16, 1987
REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROL
K873105 · JJX
Streck Laboratories, Inc.
Chemistry · 40d
Cleared Sep 16, 1987
UNIFAST CK-MB
K873134 · CGS
Sclavo, Inc.
Chemistry · 37d
Cleared Sep 14, 1987
DIAGNOSTIC KIT FREE T3 AND FREE T4
K870268 · CEC
Sclavo, Inc.
Chemistry · 234d
Cleared Sep 14, 1987
VIRON(TM)
K872646 · JJT
bioMerieux, Inc.
Chemistry · 70d
Cleared Sep 14, 1987
STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY
K873052 · CEP
American Dade
Chemistry · 41d
Cleared Sep 14, 1987
MICRO-READER II
K873138 · JJQ
Hyperion, Inc.
Chemistry · 35d
Cleared Sep 14, 1987
EASY-TEST CONJUGATED BILIRUBIN (CBIL) #16690
K873424 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 20d
Cleared Sep 11, 1987
BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052
K872073 · JIT
American Monitor Corp.
Chemistry · 105d
Cleared Sep 11, 1987
'MICROLYTE 4/5'
K873345 · JFP
Kone Instruments, Inc.
Chemistry · 23d
Cleared Sep 11, 1987
GEMENI URIC ACID U.V.
K873358 · CDO
Electro-Nucleonics Laboratories, Inc.
Chemistry · 21d
Cleared Sep 08, 1987
MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER
K872302 · JJE
Ciba Corning Diagnostics Corp.
Chemistry · 85d
Cleared Sep 08, 1987
BIOTROL TRIGLYCERIDES ENZYMATIQUE COLOR
K873160 · CDT
Biotrol, USA, Inc.
Chemistry · 28d
Cleared Sep 08, 1987
RAPID ELECTROPHORESIS SYSTEM (REP)
K873352 · JJN
Helena Laboratories
Chemistry · 19d
Cleared Sep 08, 1987
GAMMA GLUTAMYLTRANSFERASE
K873378 · JQB
Catachem, Inc.
Chemistry · 15d
Cleared Sep 08, 1987
MODEL 690 SPECTROPHOTOMETER
K873408 · JJQ
Abbott Diagnostics
Chemistry · 14d
Cleared Sep 04, 1987
BIOTROL ALPHA AMYLASE
K872831 · CIJ
Biotrol, USA, Inc.
Chemistry · 49d
Cleared Sep 04, 1987
UNIFAST GAMMA-GT
K873135 · JQB
Sclavo, Inc.
Chemistry · 25d
Cleared Sep 02, 1987
QUICK QUALITATIVE CALCIUM TEST (QUICK-CAL)
K871903 · JFN
Creative Scientific Technology, Inc.
Chemistry · 110d
Cleared Sep 02, 1987
ALLEGRO(TM) HUMAN CHORIONIC GONADOTROPIN IM SYSTEM
K872390 · JHI
Nichols Institute Diagnostics
Chemistry · 75d
Cleared Sep 02, 1987
PARAMAX URINE/CSF CALIBRATOR
K872789 · JIX
American Dade
Chemistry · 50d
Cleared Sep 02, 1987
CYBERFLUOR 615 IMMUNOANALYZER
K872803 · KHO
Cyberfluor, Inc.
Chemistry · 49d
Cleared Sep 02, 1987
MULTI ANALYTE MIXTURES, CALIBRATORS
K873116 · JIX
Biotrol, USA, Inc.
Chemistry · 23d