The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Test, Syphilis, Treponema (for Donor Testing).
Device ID | BK030007 |
510k Number | BK030007 |
Device Name: | Test, Syphilis, Treponema (FOR DONOR TESTING) |
Classification | Test, Donor, Syphilis, Antigens, Treponemal |
Applicant | Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 US |
Product Code | MYR |
CFR Regulation Number | 866.3830 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-02-07 |
Decision Date | 2003-02-21 |