The following data is part of a premarket notification filed by North American Biologicals, Inc. with the FDA for Rh Control.
Device ID | K801425 |
510k Number | K801425 |
Device Name: | RH CONTROL |
Classification | Kit, Quality Control For Blood Banking Reagents |
Applicant | NORTH AMERICAN BIOLOGICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KSF |
CFR Regulation Number | 864.9650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-06-17 |
Decision Date | 1980-07-14 |