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
2737–2760 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 30, 2004
RAICHEM GLUCOSE UV (LIQUID)
K041052 · CFR
Hemagen Diagnostics, Inc.
Chemistry · 72d
Cleared Jun 30, 2004
RAICHEM BUN RATE REAGENT (LIQUID)
K041051 · CDQ
Hemagen Diagnostics, Inc.
Chemistry · 72d
Cleared Jun 25, 2004
RAICHEM CALCIUM (OCPC) LIQUID REAGENT
K041009 · CIC
Hemagen Diagnostics, Inc.
Chemistry · 67d
Cleared Jun 25, 2004
TRIAGE PROFILER S.O.B. PANEL
K040437 · DAP
Biosite Incorporated
Chemistry · 127d
Cleared Jun 25, 2004
N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET
K040241 · DCK
Genzyme Corp.
Chemistry · 143d
Cleared Jun 18, 2004
TAIDOC CHECK
K041107 · NBW
Taidoc Technology Corporation
Chemistry · 51d
Cleared Jun 18, 2004
CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)
K040579 · DCK
Cholestech Corp.
Chemistry · 106d
Cleared Jun 17, 2004
FSH MENOPAUSE PREDICTOR TEST
K041165 · CGJ
ACON Laboratories, Inc.
Chemistry · 44d
Cleared Jun 16, 2004
RANDOX IMMUNOASSAY CONTROL
K040379 · JJY
Randox Laboratories, Ltd.
Chemistry · 120d
Cleared Jun 16, 2004
POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER
K040332 · JJF
Arkray, Inc.
Chemistry · 127d
Cleared Jun 14, 2004
ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS
K040425 · NBC
Bayer Healthcare, LLC
Chemistry · 117d
Cleared Jun 09, 2004
BIO-RAD D-10 DUAL PROGRAM
K041444 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 8d
Cleared Jun 09, 2004
RANDOX AMIKACIN
K033884 · KLQ
Randox Laboratories, Ltd.
Chemistry · 177d
Cleared Jun 08, 2004
CLEARBLUE EASY EASY READ PREGNANCY TEST
K041404 · LCX
Unipath , Ltd.
Chemistry · 13d
Cleared Jun 08, 2004
NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022
K040813 · CEW
Nichols Institute Diagnostics
Chemistry · 70d
Cleared Jun 07, 2004
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT
K040767 · LBS
Beckman Coulter, Inc.
Chemistry · 74d
Cleared Jun 02, 2004
TOTAL BILIRUBIN REAGENT SET
K040391 · CIG
Pointe Scientific, Inc.,
Chemistry · 106d
Cleared May 28, 2004
VENOJECT LUER ADAPTER
K041358 · JKA
Terumo Europe N.V.
Chemistry · 7d
Cleared May 27, 2004
MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL...
K041227 · JJY
Roche Diagnostics Corp.
Chemistry · 17d
Cleared May 21, 2004
DOCUMENT SALICYLATE CAL VER
K041073 · JJY
Microgenics Corp.
Chemistry · 25d
Cleared May 21, 2004
VITALAB IRON REAGENT
K033983 · JIY
Clinical Data, Inc.
Chemistry · 150d
Cleared May 21, 2004
Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM
K033627 · CGA
Biomedix, Inc.
Chemistry · 184d
Cleared May 20, 2004
ONE-STEP PREGNANCY TEST
K041273 · LCX
W.H.P.M., Inc.
Chemistry · 8d
Cleared May 20, 2004
CLINICAL LABORATORY ANALYZING SYSTEM
K041230 · LFR
Hemocue, Inc.
Chemistry · 10d