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510(k) K943042

BUN QVET by Prisma Systems — Product Code CDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1994
Date Received
June 27, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urease, Photometric, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

Other clearances by Prisma Systems

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  • K943027 — CHOLESTEROL QVET (January 27, 1995)
  • K942997 — ALKALINE PHOSPHATASE (ALKP) QVET (December 29, 1994)
  • K943001 — MAGNESIUM QVET (December 29, 1994)
  • K942964 — LACTATE DEHYDROGENASE QVET (December 29, 1994)
  • K942963 — GLUCOSE QVET (December 29, 1994)
  • K944102 — AST QVET (December 13, 1994)
  • K943000 — ALBUMIN QVET (December 13, 1994)
  • K943003 — CALCIUM QVET (December 9, 1994)
  • K942960 — PHOSPHATE QVET (December 9, 1994)

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  • K922969 — KING DIAGNOSTICS UREA NITROGEN REAGENT (October 13, 1992)
  • K914903 — QUICKSTART UREA NITROGEN (December 31, 1991)