PROSPECT CAMPYLOBACTER MICROPLATE ASSAY— 510(k) K982315

Name: FDA 510(k) clearance K982315
Creator: U.S. Food and Drug Administration
Published: 1998-11-18

Substantially Equivalent

Alexon - Trend, Inc.

FDA 510(k) clearance K982315 for PROSPECT CAMPYLOBACTER MICROPLATE ASSAY, Substantially Equivalent on 1998-11-18. Applicant: Alexon - Trend, Inc.. Device class: 1.

Clearance details

Applicant: Alexon - Trend, Inc.
Product code: Code LQP
Device class: Class 1
Regulation: 21 CFR 866.3110
Advisory panel: Microbiology
Date received: 1998-07-01
Decision date: 1998-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ramsey, MN, US

Download summary PDF View on FDA.gov ↗

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