ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST— 510(k) K964507
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K964507 for ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST, Substantially Equivalent on 1997-06-13. Applicant: Roche Molecular Systems, Inc..
Clearance details
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Code MKZ
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Branchburg, NJ, US
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