TANDEM - E-CKMB IMMUNOENZYMETRIC ASSAY— 510(k) K832139

Name: FDA 510(k) clearance K832139
Creator: U.S. Food and Drug Administration
Published: 1983-08-12

Substantially Equivalent

Hybritech, Inc.

FDA 510(k) clearance K832139 for TANDEM - E-CKMB IMMUNOENZYMETRIC ASSAY, Substantially Equivalent on 1983-08-12. Applicant: Hybritech, Inc.. Device class: 2.

Clearance details

Applicant: Hybritech, Inc.
Product code: Code JHY
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1983-06-27
Decision date: 1983-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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