The following data is part of a premarket notification filed by Kent Laboratories, Inc. with the FDA for Antiserum To Human Hemopexin.
Device ID | K790713 |
510k Number | K790713 |
Device Name: | ANTISERUM TO HUMAN HEMOPEXIN |
Classification | Hemopexin, Antigen, Antiserum, Control |
Applicant | KENT LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CZX |
CFR Regulation Number | 866.5490 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-04-12 |
Decision Date | 1979-09-04 |