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
3457–3480 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 26, 2001
PICCOLO CHLORIDE TEST SYSTEM
K010670 · CHJ
Abaxis, Inc.
Chemistry · 51d
Cleared Apr 26, 2001
ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT...
K004010 · LFR
Roche Diagnostics Corp.
Chemistry · 121d
Cleared Apr 26, 2001
URS-1K (KETONE TESST)
K003987 · JIN
Teco Diagnostics
Chemistry · 121d
Cleared Apr 20, 2001
DIMENSION CTNI CALIBRATOR
K010314 · JIT
Dade Behring, Inc.
Chemistry · 77d
Cleared Apr 20, 2001
DIMENSION CTNI FLEX REAGENT CARTRIDGE
K010313 · MMI
Dade Behring, Inc.
Chemistry · 77d
Cleared Apr 13, 2001
EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229
K010812 · LAR
Syva Co., Dade Behring, Inc.
Chemistry · 25d
Cleared Apr 13, 2001
WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND...
K010421 · KNK
Wiener Laboratories Saic
Chemistry · 60d
Cleared Apr 09, 2001
ATAC PAK AST REAGENT KIT
K010488 · CIT
Elan Holdings, Inc.
Chemistry · 48d
Cleared Apr 09, 2001
MULTIPLE (IZON DNA BLOOD COLLECTION KIT)
K010328 · PJE
Izon Business Products, Inc.
Chemistry · 66d
Cleared Apr 05, 2001
SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT
K010593 · JHI
Sa Scientific, Inc.
Chemistry · 36d
Cleared Mar 30, 2001
SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936
K010652 · JIX
Sigma Diagnostics, Inc.
Chemistry · 25d
Cleared Mar 29, 2001
BAYER ADVIA IMS SYSTEM
K010201 · MMI
Bayer Corp.
Chemistry · 66d
Cleared Mar 26, 2001
PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700,...
K010403 · NBW
Home Diagnostics, Inc.
Chemistry · 42d
Cleared Mar 23, 2001
JAS MAGNESIUM REAGENT
K003835 · JGJ
Jas Diagnostics, Inc.
Chemistry · 101d
Cleared Mar 23, 2001
BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING...
K003752 · JLW
Biosafe Laboratories, Inc.
Chemistry · 108d
Cleared Mar 19, 2001
RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20
K010052 · MQM
Respironics, Inc.
Chemistry · 70d
Cleared Mar 19, 2001
ACCU-CHEK INFORM METER
K003846 · LFR
Roche Diagnostics Corp.
Chemistry · 97d
Cleared Mar 19, 2001
NEOLYNX SCREENING APPLICATION MANAGER
K003584 · JNB
Micromass, Inc.
Chemistry · 119d
Cleared Mar 16, 2001
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000
K010266 · NBC
Biosite Incorporated
Chemistry · 46d
Cleared Mar 16, 2001
DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137
K010206 · KHS
Dade Behring, Inc.
Chemistry · 52d
Cleared Mar 15, 2001
N PROTEIN STANDARD UY CALIBRATOR
K003501 · JIT
Dade Behring, Inc.
Chemistry · 122d
Cleared Mar 15, 2001
RANDOX GLUCOSE (GOD/PAP)
K003346 · CGA
Randox Laboratories, Ltd.
Chemistry · 141d
Cleared Mar 14, 2001
DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND
K010061 · CEM
Dade Behring, Inc.
Chemistry · 65d
Cleared Mar 13, 2001
ALPHA DX SYSTEM
K010562 · MMI
First Medical, Inc.
Chemistry · 15d