The following data is part of a premarket notification filed by Icl Scientific with the FDA for C3pa (gbg) Properdin Factor B.
Device ID | K781016 |
510k Number | K781016 |
Device Name: | C3PA (GBG) PROPERDIN FACTOR B |
Classification | Factor B, Antigen, Antiserum, Control |
Applicant | ICL SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JZH |
CFR Regulation Number | 866.5320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-06-16 |
Decision Date | 1978-08-14 |