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 |