The following data is part of a premarket notification filed by Hyland Therapeutic Div., Travenol Laboratories with the FDA for Haemophilus Influenzae Type B Antiserum.
| Device ID | K820192 |
| 510k Number | K820192 |
| Device Name: | HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM |
| Classification | Antisera, All Types, H. Influenza |
| Applicant | HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GRP |
| CFR Regulation Number | 866.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-25 |
| Decision Date | 1982-03-11 |