The following data is part of a premarket notification filed by Blackhawk Biosystems,inc. with the FDA for Quality Control Kits For Bloodborne Pathogen Testing Of Donors.
| Device ID | BK000041 |
| 510k Number | BK000041 |
| Device Name: | Quality Control Kits For Bloodborne Pathogen Testing Of Donors |
| Classification | Kit, Test (donors), For Bloodborne Pathogen |
| Applicant | Blackhawk BioSystems,Inc. 12945 Alcosta Blvd. San Ramon, CA 94583 |
| 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 | 2000-10-06 |
| Decision Date | 2000-12-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661002581 | BK000041 | 000 |
| 00847661002574 | BK000041 | 000 |
| 00847661002567 | BK000041 | 000 |