The following data is part of a premarket notification filed by Immuno-mycologics, Inc. with the FDA for Exo-antigen Identification System Cat.# Ex1001.
| Device ID | K880029 |
| 510k Number | K880029 |
| Device Name: | EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001 |
| Classification | Antiserum, Positive Control, Blastomyces Dermatitidis |
| Applicant | IMMUNO-MYCOLOGICS, INC. P.O. BOX 1151 Norman, OK 73070 |
| Contact | Bauman, Phd |
| Correspondent | Bauman, Phd IMMUNO-MYCOLOGICS, INC. P.O. BOX 1151 Norman, OK 73070 |
| Product Code | KFH |
| CFR Regulation Number | 866.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-05 |
| Decision Date | 1988-02-24 |