The following data is part of a premarket notification filed by Dutchland Laboratories, Inc. with the FDA for Para 1 Sendai Hemagglutinin.
| Device ID | K812365 |
| 510k Number | K812365 |
| Device Name: | PARA 1 SENDAI HEMAGGLUTININ |
| Classification | Antigens, Ha (including Ha Control), Parainfluenza Virus 1-4 |
| Applicant | DUTCHLAND LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GQR |
| CFR Regulation Number | 866.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-20 |
| Decision Date | 1981-09-09 |