SIGMA DIAGNOSTICS ELECTROLYTE BUFFER— 510(k) K963540

Name: FDA 510(k) clearance K963540
Creator: U.S. Food and Drug Administration
Published: 1996-09-27

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K963540 for SIGMA DIAGNOSTICS ELECTROLYTE BUFFER, Substantially Equivalent on 1996-09-27. Applicant: Sigma Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code JFL
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 1996-09-04
Decision date: 1996-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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