The following data is part of a premarket notification filed by Nolan Biological Laboratories, Inc. with the FDA for Immunodiffussion Reagents/serological.
| Device ID | K802128 |
| 510k Number | K802128 |
| Device Name: | IMMUNODIFFUSSION REAGENTS/SEROLOGICAL |
| Classification | Antigen, Cf, B. Dermatitidis |
| Applicant | NOLAN BIOLOGICAL LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JWW |
| CFR Regulation Number | 866.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-04 |
| Decision Date | 1980-09-26 |