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510(k) K822124

Device
Titan Gel Cpk Isoenzyme System
Applicant
HELENA LABORATORIES
510(k) number
K822124
Product code
JHT
Decision
Substantially Equivalent (SESE)
Decision date
1982-11-01
Date received
1982-07-19
Regulation
862.1215
Classification name
Chromatographic Separation, Cpk Isoenzymes
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JHT#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K022409SPECTRAL'S CARDIAC STATUS CK-MB RAPID TESTSpectral Diagnostics, Inc.2002-09-30
K991299MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBIPrinceton BioMeditech Corp.1999-05-28
K930359CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305Helena Laboratories1993-04-12
K904866COULTER CK-MB ISOENZYME REAGENTCoulter Electronics, Inc.1990-12-13
K904721DSL CK-MB (DSL #3200)Diagnostic Systems Laboratories, Inc.1990-12-13
K901450MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MBIntl. Immunoassay Laboratories, Inc.1990-05-15
K896170REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083Helena Laboratories1990-02-16
K881168CREATINE KINASE (CK) ISOENZYME MBData Medical Associates, Inc.1988-11-10
K874284SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUMDiagnostic Chemicals, Ltd. (Usa)1988-01-21
K872041COULTER DART CK-MB ISOENZYME REAGENT SYSTEMCoulter Electronics, Inc.1987-09-16
K872598MICROMI-CK(TM)Intl. Immunoassay Laboratories, Inc.1987-08-03
K872592IMACK-MB(TM)Intl. Immunoassay Laboratories, Inc.1987-07-31
K831391SHOT GUN KIT FOR CK-MBSerapine Corp.1983-11-04
K823550CK-ISOZYME U.V. REAGENT SETGelman Sciences, Inc.1983-01-07
K821964125I QUICK-MB TEST KIT FOR QUANTITATIONIntl. Immunoassay Laboratories, Inc.1982-07-22