ICON STREP B IMMUNOENZYMETRIC ASSAY— 510(k) K911417

Substantially Equivalent

Hybritech, Inc.

FDA 510(k) clearance K911417 for ICON STREP B IMMUNOENZYMETRIC ASSAY, Substantially Equivalent on 1991-07-24. Applicant: Hybritech, Inc..

Clearance details

Applicant: Hybritech, Inc.
Product code: Code GTZ
Advisory panel: Microbiology
Date received: 1991-04-01
Decision date: 1991-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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