RESUBMITTED ABBOTT TESTPACK ROTAVIRUS— 510(k) K880821

Name: FDA 510(k) clearance K880821
Creator: U.S. Food and Drug Administration
Published: 1988-05-06

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K880821 for RESUBMITTED ABBOTT TESTPACK ROTAVIRUS, Substantially Equivalent on 1988-05-06. Applicant: Abbott Laboratories. Device class: 1.

Clearance details

Applicant: Abbott Laboratories
Product code: Code LIQ
Device class: Class 1
Regulation: 21 CFR 866.3405
Advisory panel: Microbiology
Date received: 1988-03-01
Decision date: 1988-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.