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 | BK930034 |
510k Number | BK930034 |
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 | 1993-12-06 |
Decision Date | 1994-07-27 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00847661004684 | BK930034 | 000 |
00847661004585 | BK930034 | 000 |