The following data is part of a premarket notification filed by Hazleton Dutchland, Inc. with the FDA for Mumps Complement Fixation & Hemagglu.
| Device ID | K832873 |
| 510k Number | K832873 |
| Device Name: | MUMPS COMPLEMENT FIXATION & HEMAGGLU |
| Classification | Antigen, Cf (including Cf Control), Mumps Virus |
| Applicant | HAZLETON DUTCHLAND, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GRC |
| CFR Regulation Number | 866.3380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-25 |
| Decision Date | 1983-12-27 |