QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT— 510(k) K853930

Name: FDA 510(k) clearance K853930
Creator: U.S. Food and Drug Administration
Published: 1985-12-10

Substantially Equivalent

Quantimetrix Corp.

FDA 510(k) clearance K853930 for QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT, Substantially Equivalent on 1985-12-10. Applicant: Quantimetrix Corp.. Device class: 2.

Clearance details

Applicant: Quantimetrix Corp.
Product code: Code CEK
Device class: Class 2
Regulation: 21 CFR 862.1635
Advisory panel: Clinical Chemistry
Date received: 1985-09-24
Decision date: 1985-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hawthorne, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CEK

view all

K992846 — HICHEM TOTAL PROTEIN REAGENT1999-10-18
K973108 — TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-501998-03-02
K980042 — CARESIDE TOTAL PROTEIN1998-02-04
K971524 — TOTAL PROTEIN OR TP1997-05-16
K961864 — CSF/URINE TOTAL PROTEIN1996-10-24

More clearances from Quantimetrix Corp.

view all

K142262 — AUTION CHECK PLUS2015-04-10
K113177 — COMPLETE D 25-OH VITAMIN D CONTROL2012-05-10
K103744 — DROPPER A1C DIABETES CONTROL2011-05-12
K062942 — QUANTIMETRIX NICOSURE COTININE URINE CONTROL2006-10-30
K062751 — MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER2006-10-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.