PROSPECT SHIGA TOXIN MICROPLATE ASSAY— 510(k) K980507

Name: FDA 510(k) clearance K980507
Creator: U.S. Food and Drug Administration
Published: 1998-04-23

Substantially Equivalent

Alexon - Trend, Inc.

FDA 510(k) clearance K980507 for PROSPECT SHIGA TOXIN MICROPLATE ASSAY, Substantially Equivalent on 1998-04-23. Applicant: Alexon - Trend, Inc.. Device class: 1.

Clearance details

Applicant: Alexon - Trend, Inc.
Product code: Code GMZ
Device class: Class 1
Regulation: 21 CFR 866.3255
Advisory panel: Microbiology
Date received: 1998-02-10
Decision date: 1998-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ramsey, MN, US

Download summary PDF View on FDA.gov ↗

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