TESTPACK PLUS STREP A— 510(k) K922345

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K922345 for TESTPACK PLUS STREP A, Substantially Equivalent on 1992-07-16. Applicant: Abbott Laboratories. Device class: 1.

Clearance details

Applicant
Abbott Laboratories
Product code
Code GTZ
Device class
Class 1
Regulation
21 CFR 866.3740
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Abbott Park, IL, US
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