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
3433–3456 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 18, 2001
CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL...
K011548 · JJY
Medical Analysis Systems, Inc.
Chemistry · 31d
Cleared Jun 18, 2001
PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY
K010553 · NBW
Abbott Laboratories
Chemistry · 112d
Cleared Jun 14, 2001
DIMENSION DRUG CALIBRATOR, MODEL DC22B
K011035 · JIX
Dade Behring, Inc.
Chemistry · 70d
Cleared Jun 13, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS
K011463 · JJX
Ortho-Clinical Diagnostics
Chemistry · 30d
Cleared Jun 13, 2001
HYDRAGEL ISO-PAL K20 (PN 3022)
K011113 · CIN
Sebia
Chemistry · 63d
Cleared Jun 08, 2001
SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO
K011465 · LDP
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Jun 07, 2001
DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132
K011033 · JIH
Dade Behring, Inc.
Chemistry · 63d
Cleared Jun 06, 2001
EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
K011528 · DLZ
Syva Co.
Chemistry · 20d
Cleared Jun 05, 2001
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345
K010429 · MMI
Beckman Coulter, Inc.
Chemistry · 112d
Cleared May 29, 2001
SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT
K010597 · DCK
Beckman Coulter, Inc.
Chemistry · 90d
Cleared May 23, 2001
CHEMWELL, MODEL 2900
K010877 · CIX
Awareness Technology, Inc.
Chemistry · 61d
Cleared May 21, 2001
ANALYST PANELS + ANALYTICAL TEST ROTOR
K010864 · KHS
Hemagen Diagnostics, Inc.
Chemistry · 60d
Cleared May 18, 2001
MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100
K011233 · CGA
Apex BioTechnology Corp.
Chemistry · 25d
Cleared May 18, 2001
HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3
K011169 · JJY
International Enzymes, Inc.
Chemistry · 31d
Cleared May 16, 2001
MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM
K011213 · JGS
Beckman Coulter, Inc.
Chemistry · 26d
Cleared May 16, 2001
N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000
K003609 · NEO
Osteometer Biotech A/S
Chemistry · 175d
Cleared May 10, 2001
MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229
K011166 · KLS
Syva Co., Dade Behring, Inc.
Chemistry · 24d
Cleared May 10, 2001
MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229
K011163 · JXN
Syva Co., Dade Behring, Inc.
Chemistry · 24d
Cleared May 08, 2001
RANDOX MYOGLOBIN
K010700 · DDR
Randox Laboratories, Ltd.
Chemistry · 61d
Cleared May 07, 2001
ATLAST DATA MANAGEMENT SOFTWARE (DMS)
K010605 · CGA
Amira Medical, Inc.
Chemistry · 68d
Cleared May 07, 2001
GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS
K010520 · CGA
Instrumentation Laboratory CO
Chemistry · 74d
Cleared May 02, 2001
RAICHEM CREATININE URINE STANDARD
K011126 · JIT
Hemagen Diagnostics, Inc.
Chemistry · 19d
Cleared May 02, 2001
SURE CHECK OVULATION PREDICTOR
K010244 · CEP
Chembio Diagnostic Systems, Inc.
Chemistry · 97d
Cleared Apr 30, 2001
TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600
K004038 · CEW
Scantibodies Laboratory, Inc.
Chemistry · 123d