The following data is part of a premarket notification filed by Blackhawk Biosystems,inc. with the FDA for Quality Control Kits For Blood Banking Reagents.
| Device ID | BK930016 |
| 510k Number | BK930016 |
| Device Name: | Quality Control Kits For Blood Banking Reagents |
| Classification | Kit, Quality Control For Blood Banking Reagents |
| Applicant | Blackhawk BioSystems,Inc. 12945 Alcosta Blvd. San Ramon, CA 94583 |
| Product Code | KSF |
| CFR Regulation Number | 864.9650 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-14 |
| Decision Date | 1993-11-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661005780 | BK930016 | 000 |
| 00847661004707 | BK930016 | 000 |
| 00847661004738 | BK930016 | 000 |
| 00847661004745 | BK930016 | 000 |
| 00847661004752 | BK930016 | 000 |
| 00847661004769 | BK930016 | 000 |
| 00847661004776 | BK930016 | 000 |
| 00847661005322 | BK930016 | 000 |
| 00847661005513 | BK930016 | 000 |
| 00847661005520 | BK930016 | 000 |
| 00847661005537 | BK930016 | 000 |
| 00847661005544 | BK930016 | 000 |
| 00847661005551 | BK930016 | 000 |
| 00847661005773 | BK930016 | 000 |
| 00847661004240 | BK930016 | 000 |