The following data is part of a premarket notification filed by Alexon - Trend, Inc. with the FDA for Prospect Shiga Toxin Microplate Assay.
Device ID | K980507 |
510k Number | K980507 |
Device Name: | PROSPECT SHIGA TOXIN MICROPLATE ASSAY |
Classification | Antigens, All Types, Escherichia Coli |
Applicant | ALEXON - TREND, INC. 14000 UNITY ST., N.W. Ramsey, MN 55303 -9115 |
Contact | Barbara A Chiponis, Mt (ascp) |
Correspondent | Barbara A Chiponis, Mt (ascp) ALEXON - TREND, INC. 14000 UNITY ST., N.W. Ramsey, MN 55303 -9115 |
Product Code | GMZ |
CFR Regulation Number | 866.3255 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-02-10 |
Decision Date | 1998-04-23 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05056080501949 | K980507 | 000 |
05056080501932 | K980507 | 000 |
05056080501673 | K980507 | 000 |