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510(k) K002559

EL-ANA PROFILES-2K1 by Theratest Laboratories, Inc. — Product Code LJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2000
Date Received
August 17, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

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  • K051066 — THERATEST EL-ANA PROFILES (October 7, 2005)
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  • K024151 — EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P (February 6, 2003)
  • K024031 — THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE (February 6, 2003)
  • K982622 — EL-ANA PROFILES: EL-ENA/5 (August 13, 1998)

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