SYSCON TURMOR MARKER CONTROL— 510(k) K955812

Name: FDA 510(k) clearance K955812
Creator: U.S. Food and Drug Administration
Published: 1996-03-12

Substantially Equivalent

Scantibodies Laboratory, Inc.

FDA 510(k) clearance K955812 for SYSCON TURMOR MARKER CONTROL, Substantially Equivalent on 1996-03-12. Applicant: Scantibodies Laboratory, Inc.. Device class: 1.

Clearance details

Applicant: Scantibodies Laboratory, Inc.
Product code: Code JJY
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1995-12-26
Decision date: 1996-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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