COBAS(R) CORE IGE TOTAL EIA— 510(k) K930890

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K930890 for COBAS(R) CORE IGE TOTAL EIA, Substantially Equivalent on 1993-08-05. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code DGC
Advisory panel: Immunology
Date received: 1993-02-22
Decision date: 1993-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

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