The following data is part of a premarket notification filed by Acrometrix Corporation with the FDA for Quality Control Kits For Bloodborne Pathogen Testing Of Donors.
| Device ID | BK050061 |
| 510k Number | BK050061 |
| Device Name: | Quality Control Kits For Bloodborne Pathogen Testing Of Donors |
| Classification | Kit, Test (donors), For Bloodborne Pathogen |
| Applicant | AcroMetrix Corporation 6058 Egret Court Benicia, CA 94510 US |
| Product Code | MYZ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-18 |
| Decision Date | 2005-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883006270 | BK050061 | 0 |
| 00884883005907 | BK050061 | 0 |