The following data is part of a premarket notification filed by Biotest Medical Diagnostics Gmbh with the FDA for Quality Control Kits For Blood Banking Reagents.
| Device ID | BK080012 |
| 510k Number | BK080012 |
| Device Name: | Quality Control Kits For Blood Banking Reagents |
| Classification | Kit, Quality Control For Blood Banking Reagents |
| Applicant | Biotest Medical Diagnostics GmbH p.o. Box 10 21 50 63267 Dreiech, GM |
| 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 | 2008-03-17 |
| Decision Date | 2008-07-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07611969952502 | BK080012 | 0 |
| 07611969950874 | BK080012 | 0 |