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510(k) K950177

CK QVET by Prisma Systems — Product Code CGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1995
Date Received
January 17, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

Other clearances by Prisma Systems

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  • K943042 — BUN QVET (December 29, 1994)
  • K942963 — GLUCOSE QVET (December 29, 1994)
  • K942964 — LACTATE DEHYDROGENASE QVET (December 29, 1994)
  • K943000 — ALBUMIN QVET (December 13, 1994)
  • K944102 — AST QVET (December 13, 1994)
  • K943003 — CALCIUM QVET (December 9, 1994)
  • K942961 — AMYLASE QVET (December 9, 1994)

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