The following data is part of a premarket notification filed by Microprobe Corp. with the FDA for Affirm(tm) Vpiii Microbial Ident Test For Candida.
| Device ID | K931151 |
| 510k Number | K931151 |
| Device Name: | AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA |
| Classification | Dna Probe, Yeast |
| Applicant | MICROPROBE CORP. 1725 220TH STREET, S.E., 104 Bothell, WA 98021 |
| Contact | Russel K Enns |
| Correspondent | Russel K Enns MICROPROBE CORP. 1725 220TH STREET, S.E., 104 Bothell, WA 98021 |
| Product Code | MLA |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-08 |
| Decision Date | 1993-06-18 |