URIC ACID— 510(k) K771842

Substantially Equivalent

Gamma Enterprises, Inc.

FDA 510(k) clearance K771842 for URIC ACID, Substantially Equivalent on 1977-10-25. Applicant: Gamma Enterprises, Inc.. Device class: 1.

Clearance details

Applicant: Gamma Enterprises, Inc.
Product code: Code CDH
Device class: Class 1
Regulation: 21 CFR 862.1775
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 CDH

K850933 — URIC ACID1985-06-25
K841067 — URIC ACID REAGENT SET1984-05-01
K821213 — URIC ACID REAGENT SET1982-07-13
K813076 — PHOSPHOTUNGSTATE REDUCTION, URIC ACID1981-11-16
K810088 — URIC ACID (TPTZ) COLORINMETRIC1981-01-28

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.