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510(k) K942964

LACTATE DEHYDROGENASE QVET by Prisma Systems — Product Code CFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1994
Date Received
June 23, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Device Class
Class II
Regulation Number
862.1440
Review Panel
CH
Submission Type

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  • K943001 — MAGNESIUM QVET (December 29, 1994)
  • K942963 — GLUCOSE QVET (December 29, 1994)
  • K943000 — ALBUMIN QVET (December 13, 1994)
  • K944102 — AST QVET (December 13, 1994)
  • K943003 — CALCIUM QVET (December 9, 1994)
  • K942960 — PHOSPHATE QVET (December 9, 1994)

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