The following data is part of a premarket notification filed by Karo Bio Diagnostics Ab with the FDA for Phadebact Monoclonal Gc Test, Modification.
| Device ID | K921075 |
| 510k Number | K921075 |
| Device Name: | PHADEBACT MONOCLONAL GC TEST, MODIFICATION |
| Classification | Antiserum, Coagglutination (direct) Neisseria Gonorrhoeae |
| Applicant | KARO BIO DIAGNOSTICS AB LUNASTIGEN 3 S-141 44 Huddinge, Sweden, SC |
| Contact | Bengt Gustavsson |
| Correspondent | Bengt Gustavsson KARO BIO DIAGNOSTICS AB LUNASTIGEN 3 S-141 44 Huddinge, Sweden, SC |
| Product Code | LIC |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-28 |
| Decision Date | 1992-05-22 |