FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,224 results
3433–3456 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
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