The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Premier-cryptococcal Antigen.
| Device ID | K904393 |
| 510k Number | K904393 |
| Device Name: | PREMIER-CRYPTOCOCCAL ANTIGEN |
| Classification | Antigen, Elisa, Cryptococcus |
| Applicant | MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Contact | Allen Nickol |
| Correspondent | Allen Nickol MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Product Code | MDU |
| CFR Regulation Number | 866.3165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-25 |
| Decision Date | 1991-01-25 |