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510(k) K943026

POTASSIUM QVET by Prisma Systems — Product Code CEJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1994
Date Received
June 27, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tetraphenyl Borate, Colorimetry, Potassium
Device Class
Class II
Regulation Number
862.1600
Review Panel
CH
Submission Type

Other clearances by Prisma Systems

  • K950177 — CK QVET (March 3, 1995)
  • K943027 — CHOLESTEROL QVET (January 27, 1995)
  • K942964 — LACTATE DEHYDROGENASE QVET (December 29, 1994)
  • K942963 — GLUCOSE QVET (December 29, 1994)
  • K943001 — MAGNESIUM QVET (December 29, 1994)
  • K942997 — ALKALINE PHOSPHATASE (ALKP) QVET (December 29, 1994)
  • K943042 — BUN QVET (December 29, 1994)
  • K943000 — ALBUMIN QVET (December 13, 1994)
  • K944102 — AST QVET (December 13, 1994)
  • K943003 — CALCIUM QVET (December 9, 1994)

Other clearances for product code CEJ

  • K043267 — POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2 (February 10, 2005)
  • K904033 — REFLOTRON POTASSIUM TEST TABS (November 6, 1990)
  • K902574 — POTASSIUM REAGENT SET (July 10, 1990)
  • K883585 — TECHNICON ASSIST POTASSIUM (November 29, 1988)
  • K883586 — TECHNICON RA-100 SYSTEM POTASSIUM (November 29, 1988)
  • K881440 — IQ POTASSIUM (May 27, 1988)
  • K880339 — EASY-TEST POTASSIUM K ITEM NUMBER 19XXX (February 25, 1988)
  • K863486 — POTASSIUM TEST (September 29, 1986)
  • K861713 — SERUM POTASSIUM REAGENT SET (May 23, 1986)
  • K853404 — QCA POTASSIUM TEST KIT (August 23, 1985)