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
2977–3000 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 18, 2003
LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS...
K031231 · JJW
Bio-Rad
Chemistry · 61d
Cleared Jun 17, 2003
ONE-STEP PREGNANCY TEST
K031271 · LCX
Amerisource Pharmacal, Inc.
Chemistry · 56d
Cleared Jun 17, 2003
ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)
K030528 · JIY
Clinical Data
Chemistry · 118d
Cleared Jun 16, 2003
RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2
K031101 · JJY
Hemagen Diagnostics, Inc.
Chemistry · 70d
Cleared Jun 16, 2003
CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO...
K031048 · JHI
Access Bio Incorporate
Chemistry · 75d
Cleared Jun 16, 2003
VIDAS TROPONIN I (TNI), MODEL 30 445
K030950 · MMI
bioMerieux, Inc.
Chemistry · 82d
Cleared Jun 13, 2003
CARESTART HCG ONE-STEP PREGNANCY TEST
K031052 · DHA
Access Bio Incorporate
Chemistry · 72d
Cleared Jun 10, 2003
HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY
K031348 · NHG
Salimetrics, LLC
Chemistry · 60d
Cleared Jun 06, 2003
WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET
K024280 · DCK
Wako Chemicals USA, Inc.
Chemistry · 165d
Cleared Jun 02, 2003
GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)
K031135 · CFR
Dade Behring, Inc.
Chemistry · 54d
Cleared May 30, 2003
MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3
K031364 · JJY
Medical Analysis Systems, Inc.
Chemistry · 30d
Cleared May 22, 2003
MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM
K031388 · CGA
Hypoguard USA, Inc.
Chemistry · 20d
Cleared May 22, 2003
EASYCUP
K023823 · JHI
Zer Hitech
Chemistry · 188d
Cleared May 12, 2003
ELECSYS LH CALSET II
K031299 · JIT
Roche Diagnostics Corp.
Chemistry · 18d
Cleared May 12, 2003
RANDOX AMMONIA
K030873 · JIF
Randox Laboratories, Ltd.
Chemistry · 53d
Cleared May 08, 2003
BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344,...
K030573 · JKA
Bd Vacutainer Systems Preanalyical...
Chemistry · 73d
Cleared May 02, 2003
CLEARBLUE EASY DIGITAL PREGNANCY TEST
K030659 · LCX
Unipath , Ltd.
Chemistry · 60d
Cleared May 02, 2003
GLYCA-DIRECT FRUCTOSAMINE
K023654 · LCP
Polymedco, Inc.
Chemistry · 184d
Cleared Apr 28, 2003
MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL
K030942 · JJY
Medical Analysis Systems, Inc.
Chemistry · 33d
Cleared Apr 28, 2003
MICROALBUMIN REAGENT SET AND CALIBRATORS
K023860 · DDZ
Pointe Scientific, Inc.,
Chemistry · 159d
Cleared Apr 23, 2003
PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD...
K023256 · NBW
Abbott Laboratories
Chemistry · 205d
Cleared Apr 18, 2003
POLY STAT SERUM/URINE HCG TEST
K030430 · JHI
Alidex, Inc.
Chemistry · 67d
Cleared Apr 17, 2003
ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME...
K030533 · LCX
Cenogenics Corp.
Chemistry · 62d
Cleared Apr 14, 2003
STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS
K030650 · CEN
Uridynamics, Inc.
Chemistry · 45d