The following data is part of a premarket notification filed by Immuno-mycologics, Inc. with the FDA for Rabbit Plasma Fibrinogen (rpf) Supplement.
| Device ID | K883333 |
| 510k Number | K883333 |
| Device Name: | RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT |
| Classification | Plasma, Coagulase, Human, Horse And Rabbit |
| 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 | JTL |
| CFR Regulation Number | 866.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-09 |
| Decision Date | 1988-08-25 |