The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for System, Detection, Bacterial, Detection Systems For Platelet Transfusion Products.
Device ID | BK050037 |
510k Number | BK050037 |
Device Name: | System, Detection, Bacterial, Detection Systems For Platelet Transfusion Products |
Classification | System, Detection, Bacterial, For Platelet Transfusion Products |
Applicant | bioMerieux, Inc. 100 Rodolphe Street Durham, NC 27712 US |
Product Code | MZC |
CFR Regulation Number | 866.2560 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-07-14 |
Decision Date | 2005-12-27 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
03573026126742 | BK050037 | 000 |