KINETIC CREATININE— 510(k) K830447

Substantially Equivalent

American Monitor Corp.

FDA 510(k) clearance K830447 for KINETIC CREATININE, Substantially Equivalent on 1983-03-24. Applicant: American Monitor Corp.. Device class: 2.

Clearance details

Applicant: American Monitor Corp.
Product code: Code CGX
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 1983-02-10
Decision date: 1983-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from American Monitor Corp.

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K895423 — ACCESS CHEMISTRY ANALYZER1989-10-04
K893137 — EXCEL (TM) CHEMISTRY ANALYZER1989-08-10

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