The following data is part of a premarket notification filed by Microprobe Corp. with the FDA for Affirm Vp Sample Collection Set.
| Device ID | K920536 |
| 510k Number | K920536 |
| Device Name: | AFFIRM VP SAMPLE COLLECTION SET |
| Classification | Device, Specimen Collection |
| Applicant | MICROPROBE CORP. 1725 220TH STREET, S.E., 104 Bothell, WA 98021 |
| Contact | Monica A Krieger |
| Correspondent | Monica A Krieger MICROPROBE CORP. 1725 220TH STREET, S.E., 104 Bothell, WA 98021 |
| Product Code | LIO |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-05 |
| Decision Date | 1992-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382904462505 | K920536 | 000 |
| 30382904462551 | K920536 | 000 |
| 30382904462513 | K920536 | 000 |