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510(k) K943000

ALBUMIN QVET by Prisma Systems — Product Code CIX

K943000 is an FDA 510(k) premarket notification submitted by Prisma Systems for the device "ALBUMIN QVET". The FDA issued a decision of Substantially Equivalent on December 13, 1994. The device falls under product code CIX (Bromcresol Green Dye-Binding, Albumin), a Class II device regulated under 21 CFR 862.1035. Prisma Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1994
Date Received
June 23, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bromcresol Green Dye-Binding, Albumin
Device Class
Class II
Regulation Number
862.1035
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)
  • K943001 — MAGNESIUM QVET (December 29, 1994)
  • K942963 — GLUCOSE QVET (December 29, 1994)
  • K943042 — BUN QVET (December 29, 1994)
  • K942964 — LACTATE DEHYDROGENASE QVET (December 29, 1994)
  • K944102 — AST QVET (December 13, 1994)
  • K942961 — AMYLASE QVET (December 9, 1994)
  • K943026 — POTASSIUM QVET (December 9, 1994)

Other clearances for product code CIX

  • K251157 — Core Metabolic (January 9, 2026)
  • K203248 — Albumin BCG2 (November 23, 2021)
  • K200898 — Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medic (September 21, 2021)
  • K191316 — VITROS XT Chemistry Products ALB-TP Slides (June 7, 2019)
  • K170901 — ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 (April 13, 2018)
  • K131488 — ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND (August 19, 2013)
  • K113374 — ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE P (July 13, 2012)
  • K110818 — POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEI (September 8, 2011)
  • K110830 — ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELI (June 21, 2011)
  • K101088 — EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT (April 4, 2011)

FDA data resources