AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA
FDA 510(k) clearance K931151 · decided 1993-06-18
Clearance details
- K-number
- K931151
- Device name
- AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA
- Applicant
- Microprobe Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-03-08
- Decision date
- 1993-06-18
- Days to decision
- 102 days
- Clearance type
- Traditional
- Product code
- MLA
- 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AFFIRM VPIII MICROBIAL IDENTIFICATION TEST (K931374) | Microprobe Corp. | 1993-06-15 |
Recalls involving this device
No recalls on record reference this clearance.