The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Premier Cryptosporidium.
| Device ID | K982764 |
| 510k Number | K982764 |
| Device Name: | PREMIER CRYPTOSPORIDIUM |
| Classification | Cryptosporidium Spp. |
| Applicant | MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Contact | Allen D Nickol |
| Correspondent | Allen D Nickol MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Product Code | MHJ |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-06 |
| Decision Date | 1998-12-03 |
| Summary: | summary |