GENESIS— 510(k) K953345

Substantially Equivalent

Tecan U.S., Inc.

FDA 510(k) clearance K953345 for GENESIS, Substantially Equivalent on 1995-11-21. Applicant: Tecan U.S., Inc..

Clearance details

Applicant: Tecan U.S., Inc.
Product code: Code JQW
Advisory panel: Clinical Chemistry
Date received: 1995-07-12
Decision date: 1995-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle Park, NC, US

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