ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST
FDA 510(k) clearance K853738 · decided 1985-12-06
Clearance details
- K-number
- K853738
- Device name
- ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST
- Applicant
- Ortho Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-09-06
- Decision date
- 1985-12-06
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- LJP
- Device class
- 1
- Regulation number
- 866.3120
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Carpinteria, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.