SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY— 510(k) K941496

Name: FDA 510(k) clearance K941496
Creator: U.S. Food and Drug Administration
Published: 1994-10-27

Substantially Equivalent

Solarcare, Inc.

FDA 510(k) clearance K941496 for SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY, Substantially Equivalent on 1994-10-27. Applicant: Solarcare, Inc.. Device class: 2.

Clearance details

Applicant: Solarcare, Inc.
Product code: Code CEK
Device class: Class 2
Regulation: 21 CFR 862.1635
Advisory panel: Clinical Chemistry
Date received: 1994-03-28
Decision date: 1994-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

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