TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT— 510(k) K894761

Substantially Equivalent

Hybritech, Inc.

FDA 510(k) clearance K894761 for TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT, Substantially Equivalent on 1989-09-13. Applicant: Hybritech, Inc..

Clearance details

Applicant
Hybritech, Inc.
Product code
Code CGJ
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Diego, CA, US
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