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
3385–3408 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 14, 2001
HCG STAT PAK ULTRA-FAST
K011550 · JHI
Chembio Diagnostic Systems, Inc.
Chemistry · 88d
Cleared Aug 10, 2001
GENZYME DIRECT-AMYLASE TEST REAGENT
K011843 · JFJ
Genzyme Corp.
Chemistry · 59d
Cleared Aug 10, 2001
QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD...
K010039 · NBW
Chronimed, Inc.
Chemistry · 217d
Cleared Aug 09, 2001
MODIFICATION TO ACCU-CHEK INFORM METER
K012210 · NBW
Roche Diagnostics Corp.
Chemistry · 24d
Cleared Aug 08, 2001
MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION
K012286 · LBS
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Aug 07, 2001
MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION
K012287 · MRR
Roche Diagnostics Corp.
Chemistry · 18d
Cleared Aug 07, 2001
QUIK-CHECK HOME PREGNANCY TEST
K012215 · LCX
ACON Laboratories, Inc.
Chemistry · 22d
Cleared Aug 07, 2001
PRAXSYS RELIA TSH TEST
K011527 · JLW
Praxsys Biosystems, Inc.
Chemistry · 82d
Cleared Aug 03, 2001
EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229
K012257 · DKZ
Syva Co.
Chemistry · 16d
Cleared Aug 01, 2001
AUTOMATED WORKCELL CONTROL SOFTWARE
K010500 · JJE
Lab-Interlink, Inc.
Chemistry · 161d
Cleared Jul 31, 2001
GLUCOSE (HEXOKINASE)
K011900 · CFR
Jas Diagnostics, Inc.
Chemistry · 43d
Cleared Jul 31, 2001
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS
K011658 · JIX
Rochdiag
Chemistry · 63d
Cleared Jul 30, 2001
OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE
K011052 · JMM
Ostex Intl., Inc.
Chemistry · 115d
Cleared Jul 30, 2001
BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21
K010734 · MLK
Branan Medical Corp.
Chemistry · 140d
Cleared Jul 25, 2001
HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
K011692 · LPS
Intersect Systems, Inc.
Chemistry · 55d
Cleared Jul 25, 2001
HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
K011689 · LPS
Catch, Inc.
Chemistry · 55d
Cleared Jul 25, 2001
LIPOPRINT SYSTEM, LDL SUBFRACTIONS
K010337 · JHO
Quantimetrix Corp.
Chemistry · 170d
Cleared Jul 20, 2001
ALKALINE PHOSPHATASE LIQUID REAGENT
K011599 · CJE
Jas Diagnostics, Inc.
Chemistry · 57d
Cleared Jul 20, 2001
BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT,...
K003851 · DCK
Biocheck, Inc.
Chemistry · 220d
Cleared Jul 17, 2001
UREA NITROGEN (BUN) LIQUID REAGENT
K011596 · CDQ
Jas Diagnostic, Inc.
Chemistry · 54d
Cleared Jul 17, 2001
CYCLOSPORINE CALIBRATOR
K011112 · DLJ
Dade Behring, Inc.
Chemistry · 97d
Cleared Jul 16, 2001
SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT...
K011525 · JLW
Biosafe Laboratories, Inc.
Chemistry · 60d
Cleared Jul 12, 2001
LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600
K011867 · JJY
Bio-Rad
Chemistry · 28d
Cleared Jul 09, 2001
JAS CALCIUM (ARSENAZO) REAGENT
K011441 · CJY
Jas Diagnostics, Inc.
Chemistry · 60d