ANTI DS-DNA— 510(k) K943291

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K943291 for ANTI DS-DNA, Substantially Equivalent on 1994-12-02. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code LLL
Advisory panel: Immunology
Date received: 1994-07-08
Decision date: 1994-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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