AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA
FDA 510(k) clearance K922457 · decided 1992-09-25
Clearance details
- K-number
- K922457
- Device name
- AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA
- Applicant
- Microprobe Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-05-26
- Decision date
- 1992-09-25
- Days to decision
- 122 days
- Clearance type
- Traditional
- Product code
- MJK
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Bothell, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.