ACTIVATED URIC ACID— 510(k) K830616

Substantially Equivalent

American Monitor Corp.

FDA 510(k) clearance K830616 for ACTIVATED URIC ACID, Substantially Equivalent on 1983-04-05. Applicant: American Monitor Corp.. Device class: 1.

Clearance details

Applicant: American Monitor Corp.
Product code: Code CHD
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1983-02-28
Decision date: 1983-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CHD

K841052 — CHOLESTEROL REAGENT SET1984-05-01
K821195 — CHOLESTEROL REAGENT SET1982-07-13

More clearances from American Monitor Corp.

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K896000 — ASPARTATE AMINOTRANFERASE (AST)1990-01-11
K896001 — ALANINE AMINOTRANSFERASE (ALT)1989-11-13
K895423 — ACCESS CHEMISTRY ANALYZER1989-10-04
K893137 — EXCEL (TM) CHEMISTRY ANALYZER1989-08-10

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