DEMAND TOTAL PROTEIN— 510(k) K863301

Substantially Equivalent

Cooper Biomedical, Inc.

FDA 510(k) clearance K863301 for DEMAND TOTAL PROTEIN, Substantially Equivalent on 1986-09-26. Applicant: Cooper Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Cooper Biomedical, Inc.
Product code: Code CEK
Device class: Class 2
Regulation: 21 CFR 862.1635
Advisory panel: Clinical Chemistry
Date received: 1986-08-25
Decision date: 1986-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CEK

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K980042 — CARESIDE TOTAL PROTEIN1998-02-04
K971524 — TOTAL PROTEIN OR TP1997-05-16
K961864 — CSF/URINE TOTAL PROTEIN1996-10-24

More clearances from Cooper Biomedical, Inc.

K863868 — IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT1987-02-13
K864512 — IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO1987-02-13
K861926 — WORTHINGTON HDL PRECIPITATING REAGENT SET1986-06-27
K854130 — DEMAND ETHYL ALCOHOL1985-11-05
K853949 — DEMAND ACID PHOSPHATASE REAGENT1985-10-16

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