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
3361–3384 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 24, 2001
RAICHEM MULTI-ANALYTE CALIBRATOR
K012250 · JIX
Hemagen Diagnostics, Inc.
Chemistry · 69d
Cleared Sep 24, 2001
VACUETTE EDTA K2 GEL TUBES
K012043 · PJE
Greiner Vacuette North America, Inc.
Chemistry · 87d
Cleared Sep 21, 2001
WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300
K012329 · CIX
Wiener Laboratories Saic
Chemistry · 60d
Cleared Sep 21, 2001
ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K
K010844 · NAK
Astoria-Pacific, Inc.
Chemistry · 184d
Cleared Sep 19, 2001
WIENER LAB. UREA UV CINETICA AA
K012260 · CDQ
Wiener Laboratories Saic
Chemistry · 63d
Cleared Sep 18, 2001
DS30 HCY BLOOD COLLECTION TUBES
K012152 · GIM
Drew Scientific , Ltd.
Chemistry · 69d
Cleared Sep 13, 2001
EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
K011240 · NBW
Medline Industries, Inc.
Chemistry · 143d
Cleared Sep 13, 2001
COLORMATE TLC BILITEST SYSTEM
K001687 · MQM
Chromatics Color Sciences Intl., Inc.
Chemistry · 469d
Cleared Sep 12, 2001
LIQUICHEK TDM CONTROL
K012741 · DIF
Bio-Rad
Chemistry · 27d
Cleared Sep 12, 2001
GLUCOMETER DEX TEST SENSOR
K012205 · NBW
Bayer Corp.
Chemistry · 58d
Cleared Sep 11, 2001
STRATUS CS TROPONIN I CALIBRATOR
K012233 · JIT
Dade Behring, Inc.
Chemistry · 57d
Cleared Sep 11, 2001
DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00
K010973 · JIL
Hypoguard USA, Inc.
Chemistry · 162d
Cleared Sep 06, 2001
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
K012656 · JJT
Bio-Rad
Chemistry · 24d
Cleared Sep 06, 2001
JAS CARBON DIOXIDE LIQUID REAGENT
K012332 · KHS
Jas Diagnostics, Inc.
Chemistry · 45d
Cleared Sep 06, 2001
NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS,...
K011128 · CIB
Nichols Institute Diagnostics
Chemistry · 146d
Cleared Sep 04, 2001
MODIFICATION TO N/T PROTEIN CONTROL SL
K012468 · JJY
Dade Behring, Inc.
Chemistry · 33d
Cleared Aug 30, 2001
LIQUISPX LIQUID LIPID CONTROL
K012855 · JJY
Clinical Controls Division
Chemistry · 6d
Cleared Aug 30, 2001
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY...
K012593 · LBR
Ortho-Clinical Diagnostics, Inc.
Chemistry · 20d
Cleared Aug 29, 2001
LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS...
K012513 · JJY
Bio-Rad
Chemistry · 23d
Cleared Aug 28, 2001
COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE...
K012431 · JJY
Bionostics, Inc.
Chemistry · 28d
Cleared Aug 28, 2001
WH ACCU TEST PREGNANCY TEST
K012284 · JHI
W.H.P.M., Inc.
Chemistry · 39d
Cleared Aug 27, 2001
MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3
K012430 · JJX
Bionostics, Inc.
Chemistry · 27d
Cleared Aug 27, 2001
DIRECT BILIRUBIN REAGENT
K011972 · CIG
Intersect Systems, Inc.
Chemistry · 63d
Cleared Aug 24, 2001
MODIFICATION TO ELECSYS FSH II CALSET
K012399 · JIT
Roche Diagnostics Corp.
Chemistry · 28d