BIOMEK SL WITH BIOMEK SL INCUBATOR— 510(k) K941498

Name: FDA 510(k) clearance K941498
Creator: U.S. Food and Drug Administration
Published: 1994-07-14

Substantially Equivalent

Beckman Analytical and Biotechnology Development

FDA 510(k) clearance K941498 for BIOMEK SL WITH BIOMEK SL INCUBATOR, Substantially Equivalent on 1994-07-14. Applicant: Beckman Analytical and Biotechnology Development. Device class: 1.

Clearance details

Applicant: Beckman Analytical and Biotechnology Development
Product code: Code JQW
Device class: Class 1
Regulation: 21 CFR 862.2750
Advisory panel: Clinical Chemistry
Date received: 1994-03-28
Decision date: 1994-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fullerton, CA, US

Download summary PDF View on FDA.gov ↗

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