BAKER CKMB REAGENT SET— 510(k) K845024

Substantially Equivalent

Hybritech, Inc.

FDA 510(k) clearance K845024 for BAKER CKMB REAGENT SET, Substantially Equivalent on 1985-01-18. 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: 1984-12-27
Decision date: 1985-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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