MODIFIED PK300 AUTOMATIC EIA ANALYZER— 510(k) K893768

Name: FDA 510(k) clearance K893768
Creator: U.S. Food and Drug Administration
Published: 1989-08-15

Substantially Equivalent

Olympus Corp.

FDA 510(k) clearance K893768 for MODIFIED PK300 AUTOMATIC EIA ANALYZER, Substantially Equivalent on 1989-08-15. Applicant: Olympus Corp.. Device class: 1.

Clearance details

Applicant: Olympus Corp.
Product code: Code JJF
Device class: Class 1
Regulation: 21 CFR 862.2170
Advisory panel: Clinical Chemistry
Date received: 1989-05-19
Decision date: 1989-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Success, NY, US

Download summary PDF View on FDA.gov ↗

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