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
2713–2736 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 16, 2004
CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION...
K041898 · JJX
Cliniqa Corporation
Chemistry · 33d
Cleared Aug 16, 2004
N LATEX CYSTATIN
K041878 · NDY
Dade Behring, Inc.
Chemistry · 35d
Cleared Aug 16, 2004
INTERLAB MICROCAL SERUM CONTROLS
K041871 · JJX
Trouble Shooter Consuling, Inc.
Chemistry · 38d
Cleared Aug 16, 2004
G5 I HBA1C TEST, G5 II HBA1C TEST
K041635 · LCP
Provalis Diagnostics , Ltd.
Chemistry · 61d
Cleared Aug 16, 2004
ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL...
K041194 · JJX
Medical Analysis Systems, Inc.
Chemistry · 102d
Cleared Aug 12, 2004
ARCHITECT STAT TROPONIN-I IMMUNOASSAY
K041192 · MMI
Fisher Diagnostics
Chemistry · 98d
Cleared Aug 11, 2004
HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE
K041728 · JHI
Immunostics Inc.,
Chemistry · 47d
Cleared Aug 11, 2004
EZ SMART
K040848 · NBW
Vip International Wholesalers, Corp.
Chemistry · 132d
Cleared Aug 09, 2004
AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND...
K041748 · LCX
Azog, Inc.
Chemistry · 41d
Not Cleared Jul 28, 2004
CEDIA SIROLIMUS ASSAY
DEN040008 · NRP
Microgenics Corp.
Chemistry · 41d
Cleared Jul 27, 2004
N APOLIPOPROTEIN STANDARD SERUM
K041870 · JIX
Dade Behring, Inc.
Chemistry · 18d
Cleared Jul 27, 2004
MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND...
K041812 · JJY
Roche Diagnostics Corp.
Chemistry · 21d
Cleared Jul 23, 2004
PTS PANELS CHOL+GLU TEST PANEL
K041750 · NBW
Polymer Technology Systems, Inc.
Chemistry · 24d
Cleared Jul 22, 2004
LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA
K040923 · JLS
Ibl GmbH
Chemistry · 105d
Cleared Jul 21, 2004
ARCHITECT STAT CK-MB IMMUNOASSAY
K041596 · JHX
Fisher Diagnostics
Chemistry · 37d
Cleared Jul 20, 2004
DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBNP CALIBRATOR,...
K041417 · NBC
Dade Behring, Inc.
Chemistry · 54d
Cleared Jul 20, 2004
FERTELL MALE FERTILITY TEST
K041039 · POV
Genosis , Ltd.
Chemistry · 89d
Cleared Jul 16, 2004
OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524
K041793 · JMO
Olympus America, Inc.
Chemistry · 14d
Cleared Jul 14, 2004
TSH-CTK-3 IRMA
K041014 · JLW
DiaSorin, Inc.
Chemistry · 85d
Cleared Jul 14, 2004
EUSURE BLOOD GLUCOSE MONITORING SYSTEM
K040678 · NBW
Eumed Biotechnology Co., Ltd.
Chemistry · 121d
Cleared Jul 06, 2004
LIQUICHEK WHOLE BLOOD VOLATILES CONTROL
K041561 · DIF
Bio-Rad
Chemistry · 26d
Cleared Jul 06, 2004
PTS PANELS LDL CHOLESTEROL TEST STRIPS
K040693 · MRR
Polymer Technology Systems, Inc.
Chemistry · 111d
Cleared Jul 06, 2004
TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS
K040459 · JJY
Biosite Incorporated
Chemistry · 134d
Cleared Jul 02, 2004
MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
K041133 · CDD
Bayer Healthcare, LLC
Chemistry · 63d