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510(k) K940588

ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT by Helix Diagnostics, Inc. — Product Code LKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1994
Date Received
February 8, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Rnp 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)
  • K954723 — ENZYME IMMUNOASSAY ANA SCREENING TEST KIT (December 15, 1995)
  • K954700 — ENZYME IMMUNOASSAY LUPUS SCREEN 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)

Other clearances for product code LKO

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  • K140224 — EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) (December 9, 2014)
  • K123261 — EUROIMMUN ANTI-NRNP/SM ELISA (IGG) (June 12, 2013)
  • K083117 — ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODEL (May 28, 2009)
  • K071210 — MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 (December 19, 2007)
  • K022017 — RHIGENE MESACUP-2 TEST RNP, MODEL M7741 (August 14, 2002)
  • K000752 — RHIGENE MESACUP2 TEST- RNP (May 9, 2000)
  • K993589 — VARELISA RNP ANTIBODIES (November 26, 1999)
  • K990624 — AUTOSTAT II ANTI-SM/RNP ELISA (April 28, 1999)
  • K984476 — LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207 (December 22, 1998)