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510(k) K954897

HYTEC AUTOIMMUNE KITS (RNP) by Hycor Biomedical, Inc. — Product Code LKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1996
Date Received
September 19, 1995
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

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Other clearances for product code LKO

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  • 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)