The following data is part of a premarket notification filed by Remel, Inc. with the FDA for Par-one.
| Device ID | K981391 |
| 510k Number | K981391 |
| Device Name: | PAR-ONE |
| Classification | Device, Specimen Collection |
| Applicant | REMEL, INC. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Contact | Mary Ann Silvius |
| Correspondent | Mary Ann Silvius REMEL, INC. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Product Code | LIO |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-17 |
| Decision Date | 1998-07-14 |