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510(k) K082226

Device
S40 CREATINE KINASE (CK)
Applicant
Alfa Wassermann Diagnostic Technologies, Inc.
510(k) number
K082226
Product code
JHS
Decision
Substantially Equivalent (SESE)
Decision date
2008-09-18
Date received
2008-08-07
Regulation
862.1215
Classification name
Differential Rate Kinetic Method, Cpk Or Isoenzymes
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DENNIS TASCHEK
Address
4 Henderson Dr. West Caldwell NJ US 07006 07006

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JHS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K160570Creatine KinaseRoche Diagnostics Operations (Rdo)2016-05-25
K102706CKMB UDR ASSAYSENTINEL CH. SpA2011-08-19
K062128THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYSDade Behring, Inc.2006-08-21
K990439CARESIDE CKCareside, Inc.1999-04-19
K990434CARESIDE CKMBCareside, Inc.1999-04-19
K981495IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS)Diagnostic Products Corp.1998-06-10
K962126ACS CKMB II IMMUNOASSAYCiba Corning Diagnostics Corp.1996-06-21
K952250STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIMER HIGH SAMPLE DILUENTDade Intl., Inc.1995-07-17
K945083ACCESS CK-MB REAGENTSBio-Rad Laboratories, Inc.1994-11-21
K943024KINASE ISOENZYMEDupont Medical Products1994-08-02
K941584CREATINE KINASE METHODDupont Medical Products1994-07-06
K903025ROCHE ISOMUNE- CKRoche Diagnostic Systems, Inc.1990-08-09
K900806STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYBaxter Healthcare Corp1990-03-23
K883223CHECK-MMIntl. Immunoassay Laboratories, Inc.1988-09-30
K872029UNI-FAST CREATINE KINASE TEST (CK)Sclavo, Inc.1987-06-17