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
8161–8184 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 20, 1987
RESULT PLUS/HCG PREGNANCY TEST
K872730 · JHI
Ortho Diagnostic Systems, Inc.
Chemistry · 104d
Cleared Oct 20, 1987
STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY
K873051 · CGJ
American Dade
Chemistry · 77d
Cleared Oct 20, 1987
SODIUM AND POTASSIUM BY ION SELECTIVE
K873074 · JGS
American Monitor Corp.
Chemistry · 75d
Cleared Oct 20, 1987
ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL
K873250 · CIJ
Roche Diagnostic Systems, Inc.
Chemistry · 64d
Cleared Oct 20, 1987
BILE ACIDS CONTROLS
K873342 · JJX
Sigma Diagnostics, Inc.
Chemistry · 62d
Cleared Oct 20, 1987
TITAN GEL LDH REP SYSTEM
K873386 · CFE
Helena Laboratories
Chemistry · 57d
Cleared Oct 20, 1987
TITAN GEL CPK REP SYSTEM
K873399 · JHX
Helena Laboratories
Chemistry · 57d
Cleared Oct 20, 1987
PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH
K873431 · JLS
Serono Diagnostics, Inc.
Chemistry · 55d
Cleared Oct 20, 1987
IL 35260, IL TEST AMYLASE REAGENT
K873572 · CIJ
Instrumentation Laboratory CO
Chemistry · 48d
Cleared Oct 20, 1987
A-QC CLINICAL CHEMISTRY CONTROL
K873611 · JJY
Arden Medical Systems, Inc.
Chemistry · 42d
Cleared Oct 20, 1987
CHEMELIA ENZYME IMMUNOASSAY FOR (TSH)
K873625 · JLM
Boots-Celltech Diagnostics, Inc.
Chemistry · 42d
Cleared Oct 20, 1987
OSMOMETER MODEL 110
K873642 · JJM
Advanced Instruments, Inc.
Chemistry · 41d
Cleared Oct 20, 1987
MULTICHEM CREATININE REAGENT S0917
K873725 · CGX
Simmler, Inc.
Chemistry · 35d
Cleared Oct 19, 1987
URIC ACID PAP
K873363 · KNK
Boehringer Mannheim Corp.
Chemistry · 59d
Cleared Oct 19, 1987
GEMSTAR II SYSTEM
K873617 · JJE
Electro-Nucleonics Laboratories, Inc.
Chemistry · 41d
Cleared Oct 19, 1987
CIBA CORNING/SHIMADZU MODEL 570 CHEM. ANALYZER
K873749 · JJE
Ciba Corning Diagnostics Corp.
Chemistry · 34d
Cleared Oct 09, 1987
MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT
K873355 · CFT
Medix Biotech, Inc.
Chemistry · 50d
Cleared Oct 09, 1987
MULTI-ACCESS REAGENT DISPENSER
K873416 · JQW
Electro-Nucleonics Laboratories, Inc.
Chemistry · 45d
Cleared Oct 07, 1987
MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT
K873668 · CEP
Medix Biotech, Inc.
Chemistry · 27d
Cleared Oct 07, 1987
MULTICHEM ALKALINE PHOSPHATASE (S0903)
K873761 · CJE
Simmler, Inc.
Chemistry · 21d
Cleared Oct 06, 1987
BNP-AMYLASE TEST
K873133 · JFJ
Sclavo, Inc.
Chemistry · 57d
Cleared Oct 06, 1987
AFFINITY HCG IMMUNIT (POLYCLONAL)
K873524 · JHI
Bd Becton Dickinson Vacutainer...
Chemistry · 35d
Cleared Oct 02, 1987
ANSWER OVULATION TEST KIT
K871241 · CEP
Armkel, LLC
Chemistry · 189d
Cleared Oct 02, 1987
BINAX L.S. TSH IRMA TEST KIT
K873303 · JLW
Binax, Inc.
Chemistry · 45d