The following data is part of a premarket notification filed by Alexon - Trend, Inc. with the FDA for Modification To Prospect Cryptosporidium Microtiter Assay.
| Device ID | K982709 |
| 510k Number | K982709 |
| Device Name: | MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY |
| Classification | Cryptosporidium 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 | MHJ |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-04 |
| Decision Date | 1998-09-03 |