Cleared Traditional

S40 CREATINE KINASE (CK)

K082226 · Alfa Wassermann Diagnostic Technologies, Inc. · Chemistry
Sep 2008
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K082226 is an FDA 510(k) clearance for the S40 CREATINE KINASE (CK), a Differential Rate Kinetic Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHS), submitted by Alfa Wassermann Diagnostic Technologies, Inc. (West Caldwell, US). The FDA issued a Cleared decision on September 18, 2008, 42 days after receiving the submission on August 7, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K082226 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 2008
Decision Date September 18, 2008
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JHS — Differential Rate Kinetic Method, Cpk Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

Similar Devices — JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes

All 37
Creatine Kinase
K160570 · Roche Diagnostics Operations (Rdo) · May 2016
CKMB UDR ASSAY
K102706 · SENTINEL CH. SpA · Aug 2011
THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS
K062128 · Dade Behring, Inc. · Aug 2006
CARESIDE CKMB
K990434 · Careside, Inc. · Apr 1999
CARESIDE CK
K990439 · Careside, Inc. · Apr 1999
IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS)
K981495 · Diagnostic Products Corp. · Jun 1998

More from Alfa Wassermann Diagnostic...

View all
ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT
K131975 · CFJ · Oct 2013
ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
K123953 · KHS · May 2013
ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE
K123018 · CFR · Apr 2013
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT
K122757 · CHH · Oct 2012
ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT
K113389 · CDN · Aug 2012