The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Para-pak Spincon.
| Device ID | K980077 |
| 510k Number | K980077 |
| Device Name: | PARA-PAK SPINCON |
| Classification | Device, Parasite Concentration |
| Applicant | MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Contact | Allan D Nickol |
| Correspondent | Allan D Nickol MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Product Code | LKS |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-08 |
| Decision Date | 1998-04-02 |
| Summary: | summary |