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 |