The following data is part of a premarket notification filed by Diagnostica, Inc. with the FDA for H. Influenza B Antisera For Cie.
| Device ID | K823348 |
| 510k Number | K823348 |
| Device Name: | H. INFLUENZA B ANTISERA FOR CIE |
| Classification | Antisera, All Types, H. Influenza |
| Applicant | DIAGNOSTICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GRP |
| CFR Regulation Number | 866.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-09 |
| Decision Date | 1982-12-28 |