DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS— 510(k) K905829

Name: FDA 510(k) clearance K905829
Creator: U.S. Food and Drug Administration
Published: 1991-01-30

Substantially Equivalent

Kamiya Biomedical Co.

FDA 510(k) clearance K905829 for DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS, Substantially Equivalent on 1991-01-30. Applicant: Kamiya Biomedical Co.. Device class: 1.

Clearance details

Applicant: Kamiya Biomedical Co.
Product code: Code CEL
Device class: Class 1
Regulation: 21 CFR 862.1575
Advisory panel: Clinical Chemistry
Date received: 1990-12-31
Decision date: 1991-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thousand Oaks, CA, US

Download summary PDF View on FDA.gov ↗

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