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 |