SANDARE FAST 340 PHOSPHOROUS PROCEDURE— 510(k) K800297

Name: FDA 510(k) clearance K800297
Creator: U.S. Food and Drug Administration
Published: 1980-03-05

Substantially Equivalent

Sandare Chemical Co., Inc.

FDA 510(k) clearance K800297 for SANDARE FAST 340 PHOSPHOROUS PROCEDURE, Substantially Equivalent on 1980-03-05. Applicant: Sandare Chemical Co., Inc.. Device class: 1.

Clearance details

Applicant: Sandare Chemical Co., Inc.
Product code: Code CEO
Device class: Class 1
Regulation: 21 CFR 862.1580
Advisory panel: Clinical Chemistry
Date received: 1980-02-11
Decision date: 1980-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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