EMIT-ST URINE COCAINE METABOLITE ASSAY— 510(k) K820773

Name: FDA 510(k) clearance K820773
Creator: U.S. Food and Drug Administration
Published: 1982-04-08

Substantially Equivalent

Syva Co.

FDA 510(k) clearance K820773 for EMIT-ST URINE COCAINE METABOLITE ASSAY, Substantially Equivalent on 1982-04-08. Applicant: Syva Co.. Device class: 2.

Clearance details

Applicant: Syva Co.
Product code: Code DID
Device class: Class 2
Regulation: 21 CFR 862.3900
Advisory panel: Clinical Toxicology
Date received: 1982-03-23
Decision date: 1982-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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