ABBOTT TESTPACK(TM) RSV POSITIVE CONTROL— 510(k) K882277

Name: FDA 510(k) clearance K882277
Creator: U.S. Food and Drug Administration
Published: 1988-06-22

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K882277 for ABBOTT TESTPACK(TM) RSV POSITIVE CONTROL, Substantially Equivalent on 1988-06-22. Applicant: Abbott Laboratories. Device class: 1.

Clearance details

Applicant: Abbott Laboratories
Product code: Code GQG
Device class: Class 1
Regulation: 21 CFR 866.3480
Advisory panel: Microbiology
Date received: 1988-05-31
Decision date: 1988-06-22
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.