510(k) K964355— ONTRAK TESTCUP 5 (MODIFICATION)

Substantially Equivalent

Roche Diagnostic Systems, Inc.

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code LCM
Advisory panel: Unknown
Date received: 1996-11-01
Decision date: 1996-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

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