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 |