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510(k) K170901

ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 by Biosystems S.A. — Product Code CIX

K170901 is an FDA 510(k) premarket notification submitted by Biosystems S.A. for the device "ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400". The FDA issued a decision of Substantially Equivalent on April 13, 2018. The device falls under product code CIX (Bromcresol Green Dye-Binding, Albumin), a Class II device regulated under 21 CFR 862.1035. Biosystems S.A. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2018
Date Received
March 27, 2017
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 Biosystems S.A.

  • K192730 — CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV (September 9, 2020)
  • K190495 — Transferrin (March 16, 2020)
  • K182474 — alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIR (May 2, 2019)
  • K950897 — BIOBOX TRAPTOP (SMALL, MEDIUM, LARGE AND X-LARGE) (August 24, 1995)
  • K950898 — BIOBOX WITH FUNNEL TOP (SMALL, MEDIUM, LARGE, AND X-LARGE) (August 24, 1995)
  • K950899 — LABORATORY SHARPS BARREL (June 29, 1995)

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)
  • 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)
  • K080874 — EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT (February 20, 2009)

FDA data resources