The following data is part of a premarket notification filed by Micro-bio-logics with the FDA for Neisseria - Kwik Plus.
| Device ID | K852998 |
| 510k Number | K852998 |
| Device Name: | NEISSERIA - KWIK PLUS |
| Classification | Kit, Identification, Neisseria Gonorrhoeae |
| Applicant | MICRO-BIO-LOGICS 217 OSSEO AVENUE NORTH St. Cloud, MN 56301 |
| Contact | Gerald Tjernagel |
| Correspondent | Gerald Tjernagel MICRO-BIO-LOGICS 217 OSSEO AVENUE NORTH St. Cloud, MN 56301 |
| Product Code | JSX |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-15 |
| Decision Date | 1985-07-23 |