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510(k) K943026

POTASSIUM QVET by Prisma Systems — Product Code CEJ

K943026 is an FDA 510(k) premarket notification submitted by Prisma Systems for the device "POTASSIUM QVET". The FDA issued a decision of Substantially Equivalent on December 9, 1994. The device falls under product code CEJ (Tetraphenyl Borate, Colorimetry, Potassium), a Class II device regulated under 21 CFR 862.1600. Prisma Systems has at least 10 other 510(k) clearances on record.

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)
  • K942997 — ALKALINE PHOSPHATASE (ALKP) QVET (December 29, 1994)
  • K942964 — LACTATE DEHYDROGENASE QVET (December 29, 1994)
  • K943001 — MAGNESIUM QVET (December 29, 1994)
  • K942963 — GLUCOSE QVET (December 29, 1994)
  • K943042 — BUN QVET (December 29, 1994)
  • K944102 — AST QVET (December 13, 1994)
  • K943000 — ALBUMIN QVET (December 13, 1994)
  • K942961 — AMYLASE 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)
  • K883586 — TECHNICON RA-100 SYSTEM POTASSIUM (November 29, 1988)
  • K883585 — TECHNICON ASSIST 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)

FDA data resources