The following data is part of a premarket notification filed by Idt, A Division Of Whittaker M.a. Bioproducts with the FDA for Fiax C4 Assay.
Device ID | K772114 |
510k Number | K772114 |
Device Name: | FIAX C4 ASSAY |
Classification | Complement C1q, Antigen, Antiserum, Control |
Applicant | IDT, A DIVISION OF WHITTAKER M.A. BIOPRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DAK |
CFR Regulation Number | 866.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-11-07 |
Decision Date | 1977-11-30 |