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
3265–3288 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 17, 2002
MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123
K012789 · JHO
Morax
Chemistry · 150d
Cleared Jan 17, 2002
RANDOX THEOPHYLLINE
K011771 · KLS
Randox Laboratories, Ltd.
Chemistry · 225d
Cleared Jan 15, 2002
SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT
K013978 · JFJ
Beckman Coulter, Inc.
Chemistry · 43d
Cleared Jan 15, 2002
STAT PROFILE PHOX BASIC ANALYZER
K013729 · CHL
Nova Biomedical Corp.
Chemistry · 67d
Cleared Jan 08, 2002
BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT
K013062 · MMI
Biocheck, Inc.
Chemistry · 118d
Cleared Jan 08, 2002
WAMPOLE HS-CRP ELISA
K011855 · DCN
Carter-Wallace, Inc.
Chemistry · 209d
Cleared Dec 27, 2001
VICTORCH HCG TEST STRIP
K013702 · JHI
Victorch Meditek, Inc.
Chemistry · 49d
Cleared Dec 27, 2001
VICTORCH MEDITEK'S HCG TEST CARD
K013678 · DHA
Victorch Meditek, Inc.
Chemistry · 50d
Cleared Dec 21, 2001
BIOSCANNER PLUS
K014099 · NBW
Polymer Technology Systems, Inc.
Chemistry · 8d
Cleared Dec 21, 2001
MODIFICATION TO MAS CARDIOLMMUNE TL
K013995 · JJY
Medical Analysis Systems, Inc.
Chemistry · 17d
Cleared Dec 21, 2001
STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE
K013850 · JIT
Diamond Diagnostics, Inc.
Chemistry · 31d
Cleared Dec 21, 2001
AST (SGOT)
K013698 · CIT
Jas Diagnostics, Inc.
Chemistry · 44d
Cleared Dec 21, 2001
WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002
K013652 · CIC
Wiener Laboratories Saic
Chemistry · 45d
Cleared Dec 21, 2001
ACS 180 HOMOCYSTEINE ASSAY
K013606 · LPS
Bayer Diagnostics Corp.
Chemistry · 51d
Cleared Dec 21, 2001
SPIFE 2000/3000 LIPOPROTEIN
K013466 · JHO
Helena Laboratories
Chemistry · 64d
Cleared Dec 21, 2001
WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106
K011953 · CGA
Wiener Laboratories Saic
Chemistry · 183d
Cleared Dec 18, 2001
MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)
K014034 · JFL
Beckman Coulter, Inc.
Chemistry · 11d
Cleared Dec 18, 2001
MODIFICATION TO ALPHA DX SYSTEM
K014024 · MMI
First Medical, Inc.
Chemistry · 12d
Cleared Dec 18, 2001
INVERNESS MEDICAL EARLY PREGNANCY TEST
K013907 · LCX
Cambridge Diagnostics Ireland, Ltd.
Chemistry · 22d
Cleared Dec 18, 2001
PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES
K013451 · CGZ
Phoenix Diagnostics, Inc.
Chemistry · 61d
Cleared Dec 18, 2001
ADVIA CENTAUR HOMOCYSTEINE ASSAY
K013406 · LPS
Bayer Diagnostics Corp.
Chemistry · 64d
Cleared Dec 18, 2001
DC-UIBC-CO2-CAL, MODEL SE-153
K013178 · JIX
Diagnostic Chemicals , Ltd.
Chemistry · 85d
Cleared Dec 18, 2001
RAMP MYOGLOBIN ASSAY
K012040 · DDR
Response Biomedical Corp.
Chemistry · 172d
Cleared Dec 17, 2001
HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102
K011323 · NHG
Salimetrics, LLC
Chemistry · 230d