The following data is part of a premarket notification filed by Health Research, Inc. with the FDA for Latex R. Conorii.
| Device ID | K872129 |
| 510k Number | K872129 |
| Device Name: | LATEX R. CONORII |
| Classification | Reagent, Rickettsia Serological |
| Applicant | HEALTH RESEARCH, INC. STATE OF NEW YORK DEPT. OF HEALTH CORNING TOWER Albany, NY 12201 |
| Contact | Karim E Hechemy |
| Correspondent | Karim E Hechemy HEALTH RESEARCH, INC. STATE OF NEW YORK DEPT. OF HEALTH CORNING TOWER Albany, NY 12201 |
| Product Code | LSQ |
| CFR Regulation Number | 866.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-02 |
| Decision Date | 1987-08-19 |