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
9193–9216 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 02, 1985
QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA
K853925 · JHI
Nms Pharmaceuticals, Inc.
Chemistry · 69d
Cleared Dec 02, 1985
AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER
K854028 · JIW
Verified Medical Research, Inc.
Chemistry · 62d
Cleared Nov 26, 1985
CORNING MAGIC MAB HCG RADIOIMMUNOASSAY
K854024 · JHI
Corning Medical & Scientific
Chemistry · 57d
Cleared Nov 26, 1985
TECHNICON RA-500 SYSTEM
K854345 · JJC
Technicon Instruments Corp.
Chemistry · 29d
Cleared Nov 26, 1985
RAICHEM/K.E
K854540 · JJQ
Reagents Applications, Inc.
Chemistry · 13d
Cleared Nov 25, 1985
IN-VITRO TEST FOR THE DETERMINATION OF GLUCOSE
K854177 · CGA
Clinical Data, Inc.
Chemistry · 41d
Cleared Nov 25, 1985
IN-VITRO TEST FOR THE DETERMINATION OF CREATININE
K854178 · CGX
Clinical Data, Inc.
Chemistry · 41d
Cleared Nov 25, 1985
IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL
K854179 · CHH
Clinical Data, Inc.
Chemistry · 41d
Cleared Nov 25, 1985
IN-VITRO TEST DETERMINATION TOTAL BILIRUBIN
K854180 · CIG
Clinical Data, Inc.
Chemistry · 41d
Cleared Nov 25, 1985
IN-VITRO TEST DETERMINATION OF ALBUMIN
K854181 · CIX
Clinical Data, Inc.
Chemistry · 41d
Cleared Nov 25, 1985
IN-VITRO TEST DETERMINATION OF TRIALYCERIDE
K854182 · CDT
Clinical Data, Inc.
Chemistry · 41d
Cleared Nov 25, 1985
IN-VITRO TEST DETERMINATION OF URIC ACID
K854185 · KNK
Clinical Data, Inc.
Chemistry · 41d
Cleared Nov 25, 1985
IN-VITRO TEST DETERMINATION OF SGOT (AST)
K854187 · CIS
Clinical Data, Inc.
Chemistry · 41d
Cleared Nov 25, 1985
IN VITRO TEST DETERMINATION OF INORGANIC PHOSPHORO
K854188 · CEO
Clinical Data, Inc.
Chemistry · 41d
Cleared Nov 25, 1985
ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD
K854366 · CDT
American Monitor Corp.
Chemistry · 27d
Cleared Nov 25, 1985
TDX CORTISOL
K854419 · JFT
Abbott Laboratories
Chemistry · 21d
Cleared Nov 25, 1985
TDX R OPIATES
K854421 · DJG
Abbott Laboratories
Chemistry · 21d
Cleared Nov 25, 1985
ALT(OPTIMIZED) REAGENT
K854502 · CKA
Sigma Diagnostics, Inc.
Chemistry · 13d
Cleared Nov 25, 1985
AST(OPTIMIZED) REAGENT
K854503 · CIT
Sigma Diagnostics, Inc.
Chemistry · 13d
Cleared Nov 25, 1985
TOTAL PROTEIN
K854553 · CEK
American Monitor Corp.
Chemistry · 12d
Cleared Nov 22, 1985
CALCITONIN RIA KIT
K854240 · JKR
Diagnostic Systems Laboratories, Inc.
Chemistry · 32d
Cleared Nov 22, 1985
GLUCOSE REAGENT SET (GOD/TRINDER)
K854335 · CGA
Sterling Diagnostics, Inc.
Chemistry · 25d
Cleared Nov 19, 1985
I.C.L.S. COMPULYZER
K854055 · JJG
Integrated Computerized Laboratory...
Chemistry · 47d
Cleared Nov 19, 1985
ES 22
K854243 · JJE
Boehringer Mannheim Corp.
Chemistry · 29d