TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II— 510(k) K872063

Substantially Equivalent

Hybritech, Inc.

FDA 510(k) clearance K872063 for TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II, Substantially Equivalent on 1987-06-19. Applicant: Hybritech, Inc..

Clearance details

Applicant: Hybritech, Inc.
Product code: Code JHY
Advisory panel: Clinical Chemistry
Date received: 1987-05-28
Decision date: 1987-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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