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510(k) K944325

LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN by Princeton BioMeditech Corp. — Product Code JHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1995
Date Received
September 2, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
U.V. Method, Cpk Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

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  • K942958 — CREATINE KINASE MB DETERMINATION (UV) (November 21, 1994)
  • K935924 — AXSYM CK-MB (June 21, 1994)
  • K931050 — CARDIO REP CK ISOENZYME KIT - 3310 (April 20, 1993)