ELECSYS FOLATE II CALSET II— 510(k) K042490

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K042490 for ELECSYS FOLATE II CALSET II, Substantially Equivalent on 2004-09-30. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JIT
Advisory panel: Clinical Chemistry
Date received: 2004-09-14
Decision date: 2004-09-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

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