ENCORE DS-DNA— 510(k) K923537

Substantially Equivalent

Clark Laboratories, Inc.

FDA 510(k) clearance K923537 for ENCORE DS-DNA, Substantially Equivalent on 1992-12-23. Applicant: Clark Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Clark Laboratories, Inc.
Product code: Code LRM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1992-07-16
Decision date: 1992-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blairstown, NJ, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.