The following data is part of a premarket notification filed by Bio-rad Medical Diagnostics Gmbh with the FDA for Potentiating Media For In Vitro Diagnostic Use.
| Device ID | BK130070 |
| 510k Number | BK130070 |
| Device Name: | Potentiating Media For In Vitro Diagnostic Use |
| Classification | Media, Potentiating For In Vitro Diagnostic Use |
| Applicant | Bio-Rad Medical Diagnostics GmbH industriestrasse 1 Dreieich, 63303, GM |
| Product Code | KSG |
| CFR Regulation Number | 864.9600 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-06 |
| Decision Date | 2013-11-27 |