TOTAL PROTEIN— 510(k) K771841

Substantially Equivalent

Gamma Enterprises, Inc.

FDA 510(k) clearance K771841 for TOTAL PROTEIN, Substantially Equivalent on 1977-10-25. Applicant: Gamma Enterprises, Inc.. Device class: 2.

Clearance details

Applicant: Gamma Enterprises, Inc.
Product code: Code CEK
Device class: Class 2
Regulation: 21 CFR 862.1635
Advisory panel: Clinical Chemistry
Date received: 1977-09-21
Decision date: 1977-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CEK

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 Gamma Enterprises, Inc.

K790578 — GAMMA SMAC REAGENTS1979-05-15
K780504 — CREATINE PHOSPHOKINASE (CPK)1978-05-03
K780505 — SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE1978-05-03
K780506 — CARBON DIOXIDE REAGENTS1978-05-03
K780507 — SERUM GLUTAMIC-PYRUVIC TRANSAMINASE1978-05-03

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