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
4945–4968 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 29, 1996
IRON CALIBRATOR & CALIBRATION VERIFICATION SET
K955796 · JJX
Data Medical Associates, Inc.
Chemistry · 69d
Cleared Feb 29, 1996
DSL ACTIVE PROLACTIN IRMA
K960060 · CFT
Diagnostic Systems Laboratories, Inc.
Chemistry · 56d
Cleared Feb 28, 1996
ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245
K954840 · CJE
Sigma Diagnostics, Inc.
Chemistry · 131d
Cleared Feb 23, 1996
DSL AACTIVE DHEA EIA KIT
K955114 · JKC
Diagnostic Systems Laboratories, Inc.
Chemistry · 106d
Cleared Feb 23, 1996
EASYSTAT SODIUM/POTASSIUM/CHLORIDE ANALYZER
K955374 · JGS
Medica Corp.
Chemistry · 91d
Cleared Feb 23, 1996
EASYSTAT SODIUM/POTASSIUM ANALYZER
K955375 · JGS
Medica Corp.
Chemistry · 91d
Cleared Feb 23, 1996
OPUS PROLACTIN CONTROLS
K955468 · JJX
Behring Diagnostics, Inc.
Chemistry · 85d
Cleared Feb 23, 1996
URIC ACID CATALOGE# 220-93/94/97
K955496 · KNK
Diagnostic Chemicals , Ltd.
Chemistry · 84d
Cleared Feb 22, 1996
GLUCOCHEK POCKETLAB
K951457 · CGA
Clinical Diagnostics, Inc.
Chemistry · 330d
Cleared Feb 20, 1996
MULTICHECK
K952725 · GLY
Radiometer America, Inc.
Chemistry · 251d
Cleared Feb 16, 1996
IMMULITE HGH
K955376 · CFL
Diagnostic Products Corp.
Chemistry · 84d
Cleared Feb 16, 1996
IMMULITE ACTH
K960066 · CKG
Diagnostic Products Corp.
Chemistry · 42d
Cleared Feb 15, 1996
TOTAL CO2
K951221 · KHS
Randox Laboratories, Ltd.
Chemistry · 332d
Cleared Feb 15, 1996
ACCU-CHEK ADVANTAGE TEST STRIPS
K954833 · LFR
Boehringer Mannheim Corp.
Chemistry · 118d
Cleared Feb 14, 1996
SYSCON CONTROL ASSAYED & UNASSAYED
K954247 · JJY
Scantibodies Laboratory, Inc.
Chemistry · 156d
Cleared Feb 14, 1996
IL BGGE BLOOD GAS WITH GLUCOSE SYSTEM
K955793 · CHL
Instrumentation Laboratory CO
Chemistry · 54d
Cleared Feb 14, 1996
BOEHRINGER MANNHEIM CARDIAC T TROPNIN T
K955868 · MMI
Boehringer Mannheim Corp.
Chemistry · 48d
Cleared Feb 13, 1996
AIA-PACK CPR ASSAY
K951848 · JKD
Tosoh Medics, Inc.
Chemistry · 298d
Cleared Feb 13, 1996
ROCHE REAGENT FOR GLUCOSE
K953847 · CFR
Roche Diagnostic Systems, Inc.
Chemistry · 181d
Cleared Feb 12, 1996
OLYMPUS UNSATURATED IRON BINDING CAPACITY REAGENT
K955139 · JMO
Olympus America, Inc.
Chemistry · 91d
Cleared Feb 06, 1996
VIDAS ESTRADIOL II (E2II) ASSAY
K955647 · CHP
Biomerieux Vitek, Inc.
Chemistry · 56d
Cleared Feb 06, 1996
IMMULITE TOTAL TESTOSTERONE
K955870 · CDZ
Diagnostic Products Corp.
Chemistry · 40d
Cleared Feb 05, 1996
IL TEST CHOLINESTERASE
K943367 · DIH
Instrumentation Laboratory CO
Chemistry · 572d
Cleared Feb 05, 1996
ACCESS PROGESTERONE ASSAY
K955769 · JLS
Bio-Rad Laboratories, Inc.
Chemistry · 46d