AMPLICOR CHLAMYDIA TRACHOMATIS TEST— 510(k) K922906
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K922906 for AMPLICOR CHLAMYDIA TRACHOMATIS TEST, Substantially Equivalent on 1993-06-15. Applicant: Roche Molecular Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Product code MKZ
- Device class
- Class 1
- Regulation
- 21 CFR 866.3120
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Branchburg, NJ, US
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