K981391 is an FDA 510(k) clearance for the PAR-ONE. This device is classified as a Device, Specimen Collection (Class I - General Controls, product code LIO).
Submitted by Remel, Inc. (Lenexa, US). The FDA issued a Cleared decision on July 14, 1998, 88 days after receiving the submission on April 17, 1998.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2900.
| 510(k) Number | K981391 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 1998 |
| Decision Date | July 14, 1998 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LIO — Device, Specimen Collection |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2900 |