CHOLESTEROL— 510(k) K771833

Substantially Equivalent

Gamma Enterprises, Inc.

FDA 510(k) clearance K771833 for CHOLESTEROL, Substantially Equivalent on 1977-10-18. Applicant: Gamma Enterprises, Inc.. Device class: 1.

Clearance details

Applicant: Gamma Enterprises, Inc.
Product code: Code CGO
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1977-09-21
Decision date: 1977-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CGO

K850938 — CHOLESTEROL1985-06-25
K811747 — KING DIAGNOSTICS CHOLESTEROL TEST1981-07-10
K810090 — CHOLESTEROL REAGENT1981-01-26
K800682 — REAGENTS FOR DETERM. CHOLESTEROL/SERUM1980-05-28
K781611 — CHOLESTEROL DET. IN SERUM1978-10-24

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.