The following data is part of a premarket notification filed by Health Research, Inc. with the FDA for Latex R. Typhi.
| Device ID | K860557 |
| 510k Number | K860557 |
| Device Name: | LATEX R. TYPHI |
| Classification | Antiserum, Murine Typhus Fever |
| Applicant | HEALTH RESEARCH, INC. 1315 EMPIRE STATE PLAZA MAYOR ERASTUS CORNING 2 TOWER Albany, NY 12237 |
| Contact | Michael G Barth |
| Correspondent | Michael G Barth HEALTH RESEARCH, INC. 1315 EMPIRE STATE PLAZA MAYOR ERASTUS CORNING 2 TOWER Albany, NY 12237 |
| Product Code | GPM |
| CFR Regulation Number | 866.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-14 |
| Decision Date | 1986-04-21 |