AMPLICOR CHLAMYDIA TRACHOMATIS TEST
FDA 510(k) clearance K922906 · decided 1993-06-15
Clearance details
- K-number
- K922906
- Device name
- AMPLICOR CHLAMYDIA TRACHOMATIS TEST
- Applicant
- Roche Molecular Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-06-17
- Decision date
- 1993-06-15
- Days to decision
- 363 days
- Clearance type
- Traditional
- Product code
- MKZ
- Device class
- 1
- Regulation number
- 866.3120
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Branchburg, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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