AFFIRM VPIII MICROBIAL IDENTIFICATION TEST
FDA 510(k) clearance K931374 · decided 1993-06-15
Clearance details
- K-number
- K931374
- Device name
- AFFIRM VPIII MICROBIAL IDENTIFICATION TEST
- Applicant
- Microprobe Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-03-18
- Decision date
- 1993-06-15
- Days to decision
- 89 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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| Record | Firm | Date |
|---|---|---|
| AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA (K931151) | Microprobe Corp. | 1993-06-18 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD AffirM VPIII Microbial Identification Test recall (Z-1394-2017) | Becton Dickinson & Co. | 2017-02-27 |