DURAZYME(R) CPK— 510(k) K883504

Substantially Equivalent

American Monitor Corp.

FDA 510(k) clearance K883504 for DURAZYME(R) CPK, Substantially Equivalent on 1988-09-13. Applicant: American Monitor Corp.. Device class: 2.

Clearance details

Applicant: American Monitor Corp.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1988-08-17
Decision date: 1988-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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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

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