ABBOTT STREP A CONTROLS— 510(k) K972182

Substantially Equivalent

Abbott Diagnostics

FDA 510(k) clearance K972182 for ABBOTT STREP A CONTROLS, Substantially Equivalent on 1997-08-13. Applicant: Abbott Diagnostics. Device class: 1.

Clearance details

Applicant: Abbott Diagnostics
Product code: Code MJZ
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1997-05-29
Decision date: 1997-08-13
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.