The following data is part of a premarket notification filed by Kent Laboratories, Inc. with the FDA for Antisera To Human Fab Fragment.
Device ID | K771242 |
510k Number | K771242 |
Device Name: | ANTISERA TO HUMAN FAB FRAGMENT |
Classification | Myoglobin, Antigen, Antiserum, Control |
Applicant | KENT LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DDR |
CFR Regulation Number | 866.5680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-07-11 |
Decision Date | 1977-08-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B176131 | K771242 | 000 |