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510(k) K931495

ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT by Helix Diagnostics, Inc. — Product Code LLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1993
Date Received
March 25, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extractable Antinuclear Antibody, Antigen And Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Helix Diagnostics, Inc.

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  • K980337 — DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM (May 12, 1998)
  • K960091 — ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT (March 20, 1996)
  • K954700 — ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT (December 15, 1995)
  • K954723 — ENZYME IMMUNOASSAY ANA SCREENING TEST KIT (December 15, 1995)
  • K952253 — ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT (August 24, 1995)
  • K951850 — ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT (July 18, 1995)
  • K951798 — ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT (July 17, 1995)
  • K940510 — ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT (April 20, 1994)

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