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510(k) K923322

TRACE ALBUMIN-MR REAGENT by Trace Scientific , Ltd. — Product Code CIX

K923322 is an FDA 510(k) premarket notification submitted by Trace Scientific , Ltd. for the device "TRACE ALBUMIN-MR REAGENT". The FDA issued a decision of Substantially Equivalent on September 11, 1992. The device falls under product code CIX (Bromcresol Green Dye-Binding, Albumin), a Class II device regulated under 21 CFR 862.1035. Trace Scientific , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1992
Date Received
July 7, 1992
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 Trace Scientific , Ltd.

  • K982121 — ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT (September 17, 1998)
  • K981123 — UREA (April 24, 1998)
  • K962890 — CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) (September 27, 1996)
  • K961114 — AST INCORPORATING DST (May 23, 1996)
  • K961123 — ALT INCORPORATING DST (April 25, 1996)
  • K952488 — TRACE COBAS MIRA RANGE (October 13, 1995)
  • K932713 — TRACE TRANSFERRIN REAGENT (September 30, 1993)
  • K914731 — TRACE GAMMA GT-SS REAGENT (November 19, 1991)
  • K911866 — TRACE TOTAL/DIRECT BILIRUBIN REAGENT (July 17, 1991)
  • K903897 — TRIGLYCERIDES REAGENT GPO 5 X CONC. (October 1, 1990)

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