DETECT-A-STREP— 510(k) K843590

Substantially Equivalent

Antibodies, Inc.

FDA 510(k) clearance K843590 for DETECT-A-STREP, Substantially Equivalent on 1984-10-30. Applicant: Antibodies, Inc.. Device class: 1.

Clearance details

Applicant
Antibodies, Inc.
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
Davis, CA, US
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