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
4153–4176 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 12, 1998
LYPHOCHEK IMMUNOASSAY PLUS CONTROL
K981532 · JJY
Bio-Rad
Chemistry · 13d
Cleared May 07, 1998
CARESIDE GLUCOSE
K981183 · CGA
Exigent Diagnostics, Inc.
Chemistry · 36d
Cleared May 07, 1998
GLU
K981185 · CFR
Abbott Laboratories
Chemistry · 35d
Cleared May 07, 1998
URIC ACID
K981189 · CDO
Abbott Laboratories
Chemistry · 35d
Cleared May 07, 1998
OLYMPUS SERUM PROTEIN MULTICALIBRATOR
K981305 · JIX
Olympus America, Inc.
Chemistry · 27d
Cleared May 07, 1998
CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)
K981474 · JJY
Spectral Diagnostics, Inc.
Chemistry · 13d
Cleared May 06, 1998
IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE...
K980646 · MQM
Instrumentation Laboratory CO
Chemistry · 76d
Cleared May 01, 1998
REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8
K980650 · JHO
Helena Laboratories
Chemistry · 71d
Cleared May 01, 1998
IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5
K980833 · JMM
Diagnostic Products Corp.
Chemistry · 58d
Cleared May 01, 1998
MG
K981192 · JGJ
Abbott Laboratories
Chemistry · 29d
Cleared May 01, 1998
CREATINE KINASE (CK)
K981218 · CGS
Abbott Laboratories
Chemistry · 28d
Cleared May 01, 1998
IRON
K981241 · JIY
Abbott Laboratories
Chemistry · 25d
Cleared May 01, 1998
IRMA BLOOD ANALYSIS SYSTEM
K981270 · CGZ
Diametrics Medical, Inc.
Chemistry · 24d
Cleared May 01, 1998
N-ASSAY L D-BIL
K981276 · CIG
Crestat Diagnostics, Inc.
Chemistry · 23d
Cleared May 01, 1998
TBIL
K981336 · CIG
Abbott Laboratories
Chemistry · 18d
Cleared Apr 30, 1998
QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)
K973335 · JQW
Zenyx Scientific , Ltd.
Chemistry · 238d
Cleared Apr 29, 1998
ABBOTT AXSYM 3RD GENERATION TSH ASSAY
K981060 · JLW
Abbott Laboratories
Chemistry · 37d
Cleared Apr 27, 1998
HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51
K980772 · LBR
Diagnostic Chemicals , Ltd.
Chemistry · 66d
Cleared Apr 27, 1998
STRATUS CS CARDIAC TROPONIN I TESTPAK
K981098 · MMI
Dade Behring, Inc.
Chemistry · 32d
Cleared Apr 27, 1998
N-ASSAY L T-BIL
K981289 · CIG
Crestat Diagnostics, Inc.
Chemistry · 19d
Cleared Apr 24, 1998
UREA
K981123 · CDQ
Trace Scientific , Ltd.
Chemistry · 28d
Cleared Apr 24, 1998
DIRECT BILIRUBIN (DBIL)
K981222 · CIG
Abbott Laboratories
Chemistry · 21d
Cleared Apr 24, 1998
ELECSYS CALCHECK FERRITIN
K981281 · JJX
Roche Diagnostics GmbH
Chemistry · 16d
Cleared Apr 24, 1998
DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109
K981436 · JIX
Casco Standards
Chemistry · 10d