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510(k) K954106

THERATEST LAB, INC., EL-ANASCR KIT by Theratest Laboratories, Inc. — Product Code LJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1995
Date Received
August 1, 1995
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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  • K024151 — EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P (February 6, 2003)
  • K002559 — EL-ANA PROFILES-2K1 (September 12, 2000)

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