STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA— 510(k) K950308

Name: FDA 510(k) clearance K950308
Creator: U.S. Food and Drug Administration
Published: 1995-04-14

Substantially Equivalent

Solarcare Technologies Corp,Inc.

FDA 510(k) clearance K950308 for STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA, Substantially Equivalent on 1995-04-14. Applicant: Solarcare Technologies Corp,Inc.. Device class: 1.

Clearance details

Applicant: Solarcare Technologies Corp,Inc.
Product code: Code JXS
Device class: Class 1
Regulation: 21 CFR 874.3540
Advisory panel: Ear, Nose, Throat
Date received: 1995-01-25
Decision date: 1995-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

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