TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY— 510(k) K823507

Substantially Equivalent

Hybritech, Inc.

FDA 510(k) clearance K823507 for TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY, Substantially Equivalent on 1982-12-28. Applicant: Hybritech, Inc..

Clearance details

Applicant: Hybritech, Inc.
Product code: Code DGC
Advisory panel: Immunology
Date received: 1982-11-24
Decision date: 1982-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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