The following data is part of a premarket notification filed by Health Research, Inc. with the FDA for Latex-r Rickettsii.
| Device ID | K843794 |
| 510k Number | K843794 |
| Device Name: | LATEX-R RICKETTSII |
| Classification | Antiserum, Rocky Mountain Spotted Fever |
| Applicant | HEALTH RESEARCH, INC. 1315 EMPIRE STATE PLAZA MAYOR ERASTUS CORNING 2 TOWER Albany, NY 12237 |
| Contact | Roger S Rosenthal |
| Correspondent | Roger S Rosenthal HEALTH RESEARCH, INC. 1315 EMPIRE STATE PLAZA MAYOR ERASTUS CORNING 2 TOWER Albany, NY 12237 |
| Product Code | GPP |
| CFR Regulation Number | 866.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-27 |
| Decision Date | 1985-01-04 |