SNAP(R) ROTAVIRUS DIAGNOSTIC KIT— 510(k) K873565

Name: FDA 510(k) clearance K873565
Creator: U.S. Food and Drug Administration
Published: 1988-05-13

Substantially Equivalent

Molecular Biosystems, Inc.

FDA 510(k) clearance K873565 for SNAP(R) ROTAVIRUS DIAGNOSTIC KIT, Substantially Equivalent on 1988-05-13. Applicant: Molecular Biosystems, Inc.. Device class: 1.

Clearance details

Applicant: Molecular Biosystems, Inc.
Product code: Code LIO
Device class: Class 1
Regulation: 21 CFR 866.2900
Advisory panel: Microbiology
Date received: 1987-09-02
Decision date: 1988-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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