TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT— 510(k) K860778

Substantially Equivalent

Hybritech, Inc.

FDA 510(k) clearance K860778 for TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT, Substantially Equivalent on 1986-04-04. Applicant: Hybritech, Inc..

Clearance details

Applicant: Hybritech, Inc.
Product code: Code GTZ
Advisory panel: Microbiology
Date received: 1986-03-03
Decision date: 1986-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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