The following data is part of a premarket notification filed by Bartels Immunodiagnostic Supplies, Inc. with the FDA for Immunoper-oxidase Test Kit For Detect Of.
| Device ID | K842830 |
| 510k Number | K842830 |
| Device Name: | IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF |
| Classification | Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 |
| Applicant | BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. NY 12839 - |
| Product Code | GQN |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-20 |
| Decision Date | 1985-11-26 |