GAMMA-GT REAGENT SYSTEM— 510(k) K810434

Substantially Equivalent

American Monitor Corp.

FDA 510(k) clearance K810434 for GAMMA-GT REAGENT SYSTEM, Substantially Equivalent on 1981-02-26. Applicant: American Monitor Corp.. Device class: 1.

Clearance details

Applicant: American Monitor Corp.
Product code: Code JQB
Device class: Class 1
Regulation: 21 CFR 862.1360
Advisory panel: Clinical Chemistry
Date received: 1981-02-19
Decision date: 1981-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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More clearances from American Monitor Corp.

K895999 — PHOSPHORUS1990-01-11
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

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