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510(k) K935924

Device
Axsym Ck-mb
Applicant
ABBOTT LABORATORIES
510(k) number
K935924
Product code
JHW
Decision
Substantially Equivalent (SESE)
Decision date
1994-06-21
Date received
1993-12-13
Regulation
862.1215
Classification name
U.V. Method, Cpk 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
JOY C SONSALLA
Address
One Abbott Park Rd. D389, Ap30 Abbott Park IL US 60064 60064

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JHW#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K162526Creatine Kinase-MBRoche Diagnostics2017-05-26
K141265ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KITElitechgroup2014-07-18
K122083ELITECH CLINICAL SYSTEMS CK NAC SLElitechgroup2012-08-22
K023744WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354Wiener Laboratories Saic2003-01-03
K003158ROCHE DIAGNOSTICS CK-MBRoche Diagnostics Corp.2000-12-18
K961501ELECSYS CK-MBBoehringer Mannheim Corp.1996-06-11
K950186CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEMMiles, Inc.1995-03-13
K944325LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGNPrinceton BioMeditech Corp.1995-02-22
K942958CREATINE KINASE MB DETERMINATION (UV)Biochemical Trade, Inc.1994-11-21
K931050CARDIO REP CK ISOENZYME KIT - 3310Helena Laboratories1993-04-20
K913349STAMBI-CKIntl. Immunoassay Laboratories, Inc.1991-10-23
K912231PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KITIntl. Immunoassay Laboratories, Inc.1991-07-08
K905588CREATINE KINASE UV REAGENT SETBiochemical Trade, Inc.1991-01-17
K903508LABELLING CHANGES TO IMPRES-MB-XIntl. Immunoassay Laboratories, Inc.1990-09-07
K883222ISOFOR-MM (TM)Intl. Immunoassay Laboratories, Inc.1988-09-30