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
5977–6000 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 29, 1992
OLYUMPUS TOTAL PROTEIN REAGENT
K924659 · CEK
Olympus Corp.
Chemistry · 105d
Cleared Dec 28, 1992
GLUCOSE TEST SYSTEM
K923587 · CGA
Polymer Technology Corp.
Chemistry · 188d
Cleared Dec 28, 1992
ALBUMIN TEST
K923959 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 144d
Cleared Dec 28, 1992
ELECTROPHORESIS TANK
K924020 · JJN
The Binding Site, Ltd.
Chemistry · 139d
Cleared Dec 28, 1992
VACUPLUS TUBES WITH BRICK RED STOPPERS
K924365 · JKA
Starplex Scientific, Inc.
Chemistry · 122d
Cleared Dec 28, 1992
AIA-PACK BHCG CALIBRATION VERIFICATION TEST SET
K924853 · JJX
Tosoh Medics, Inc.
Chemistry · 91d
Cleared Dec 28, 1992
AIA-PACK HCG CALIBRATION VERIFICATION TEST SET
K924862 · JJX
Tosoh Medics, Inc.
Chemistry · 91d
Cleared Dec 28, 1992
CONCEIVE ONE-STEP PREGNANCY TEST
K925096 · LCX
Quidel Corp.
Chemistry · 81d
Cleared Dec 28, 1992
BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE
K925132 · JLW
Becton Dickinson Advanced Diagnostics
Chemistry · 76d
Cleared Dec 28, 1992
CIBA CORNING ACS T UPTAKE IMMUNOASSAY
K925257 · KHQ
Ciba Corning Diagnostics Corp.
Chemistry · 70d
Cleared Dec 28, 1992
MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT
K925436 · CDP
Medix Biotech, Inc.
Chemistry · 61d
Cleared Dec 28, 1992
CREATININE METH FOR USE ON THE DIMENSION CLIN CHEM
K925668 · CGX
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 48d
Cleared Dec 28, 1992
REP E-Z CK-30 ISOENZYME KIT
K925801 · CGS
Helena Laboratories
Chemistry · 42d
Cleared Dec 28, 1992
CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3
K926015 · JJX
Cala Diagnostics
Chemistry · 28d
Cleared Dec 24, 1992
HCG STAT-PAK
K923925 · JHI
Chembio Diagnostic Systems, Inc.
Chemistry · 141d
Cleared Dec 23, 1992
UNI-CHECK REAGENT STRIP
K924398 · CGA
Diagnostic Solutions, Inc.
Chemistry · 114d
Cleared Dec 18, 1992
OLYMPUS IRON REAGENT
K924691 · JIY
Olympus Corp.
Chemistry · 92d
Cleared Dec 17, 1992
ELITE TEST STRIPS GLUCOMETER
K924499 · CGA
Heraeus Kulzer, Inc.
Chemistry · 104d
Cleared Dec 17, 1992
LIQUICHEK CK-MB CONTROL LEVELS 1,2, AND3
K925151 · JJT
Bio-Rad
Chemistry · 65d
Cleared Dec 11, 1992
LYRIS 100/120 LABORATORY INFORMATION SYSTEM
K923844 · JJQ
Biovation, Inc.
Chemistry · 133d
Cleared Dec 11, 1992
OLYMPUS CHLORIDE REAGENT
K925338 · CHJ
Olympus Corp.
Chemistry · 52d
Cleared Dec 07, 1992
ASSAY SOFTWARE FOR DPC-MARJ5 ALASTAT EIA SOFTWARE
K923879 · JQW
Diagnostic Products Corp.
Chemistry · 126d
Cleared Dec 03, 1992
ALKALINE PHOSPHATASE KIT
K923507 · CJE
Randox Laboratories, Ltd.
Chemistry · 141d
Cleared Dec 03, 1992
GAMMA-GT
K923509 · JPZ
Randox Laboratories, Ltd.
Chemistry · 141d