HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET— 510(k) K861855

Name: FDA 510(k) clearance K861855
Creator: U.S. Food and Drug Administration
Published: 1986-06-16

Substantially Equivalent

Sterling Diagnostics, Inc.

FDA 510(k) clearance K861855 for HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET, Substantially Equivalent on 1986-06-16. Applicant: Sterling Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Sterling Diagnostics, Inc.
Product code: Code JKF
Device class: Class 1
Regulation: 21 CFR 862.1380
Advisory panel: Clinical Chemistry
Date received: 1986-05-14
Decision date: 1986-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sterling Heights, MI, US

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