TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY— 510(k) K884085

Substantially Equivalent

Hybritech, Inc.

FDA 510(k) clearance K884085 for TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY, Substantially Equivalent on 1988-12-02. Applicant: Hybritech, Inc..

Clearance details

Applicant: Hybritech, Inc.
Product code: Code JHY
Advisory panel: Clinical Chemistry
Date received: 1988-09-27
Decision date: 1988-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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