The following data is part of a premarket notification filed by Alexon - Trend, Inc. with the FDA for Prospect Campylobacter Microplate Assay.
| Device ID | K982315 |
| 510k Number | K982315 |
| Device Name: | PROSPECT CAMPYLOBACTER MICROPLATE ASSAY |
| Classification | Campylobacter Spp. |
| Applicant | ALEXON - TREND, INC. 14000 UNITY ST., N.W. Ramsey, MN 55303 -9115 |
| Contact | Ken Hood |
| Correspondent | Ken Hood ALEXON - TREND, INC. 14000 UNITY ST., N.W. Ramsey, MN 55303 -9115 |
| Product Code | LQP |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-01 |
| Decision Date | 1998-11-18 |