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510(k) K943003

CALCIUM QVET by Prisma Systems — Product Code CJJ

K943003 is an FDA 510(k) premarket notification submitted by Prisma Systems for the device "CALCIUM QVET". The FDA issued a decision of Substantially Equivalent on December 9, 1994. The device falls under product code CJJ (Diazo, Alt/Sgpt), a Class I device regulated under 21 CFR 862.1030. 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 23, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diazo, Alt/Sgpt
Device Class
Class I
Regulation Number
862.1030
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)
  • K942963 — GLUCOSE QVET (December 29, 1994)
  • K943001 — MAGNESIUM QVET (December 29, 1994)
  • K943042 — BUN QVET (December 29, 1994)
  • K943000 — ALBUMIN QVET (December 13, 1994)
  • K944102 — AST QVET (December 13, 1994)
  • K942961 — AMYLASE QVET (December 9, 1994)

Other clearances for product code CJJ

  • K895128 — BIOTRACK ALT TEST CARTRIDGE (October 6, 1989)

FDA data resources