ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY— 510(k) K993706

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K993706 for ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY, Substantially Equivalent on 2000-07-24. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JMM
Advisory panel: Clinical Chemistry
Date received: 1999-11-02
Decision date: 2000-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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