PHOSPHOLIPID REAGENT SET— 510(k) K914040

Name: FDA 510(k) clearance K914040
Creator: U.S. Food and Drug Administration
Published: 1991-10-30

Substantially Equivalent

Sterling Diagnostics, Inc.

FDA 510(k) clearance K914040 for PHOSPHOLIPID REAGENT SET, Substantially Equivalent on 1991-10-30. Applicant: Sterling Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Sterling Diagnostics, Inc.
Product code: Code JNT
Device class: Class 1
Regulation: 21 CFR 862.1575
Advisory panel: Clinical Chemistry
Date received: 1991-09-10
Decision date: 1991-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sterling Heights, MI, US

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