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510(k) K022017

RHIGENE MESACUP-2 TEST RNP, MODEL M7741 by Rhigene, Inc. — Product Code LKO

K022017 is an FDA 510(k) premarket notification submitted by Rhigene, Inc. for the device "RHIGENE MESACUP-2 TEST RNP, MODEL M7741". The FDA issued a decision of Substantially Equivalent on August 14, 2002. The device falls under product code LKO (Anti-Rnp Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Rhigene, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2002
Date Received
June 20, 2002
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 Rhigene, Inc.

  • K040711 — MESACUP TEST PR-3 (April 2, 2004)
  • K040586 — MESACUP TEST MPO, MODEL 11053 (March 22, 2004)
  • K040200 — MESACUP-2 TEST CENP-B (March 4, 2004)
  • K033528 — MESACUP-2 TEST JO-1, MODEL 10756 (December 22, 2003)
  • K031308 — RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 (September 26, 2003)
  • K022018 — RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560 (July 5, 2002)
  • K011068 — RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L (April 11, 2002)
  • K000336 — RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E (June 9, 2000)
  • K000755 — RHIGENE MESACUP2 TEST- SM (May 9, 2000)
  • K000751 — RHIGENE MESACUP2 TEST- SSB (May 9, 2000)

Other clearances for product code LKO

  • K191085 — Maverick RNP Assay and Maverick Diagnostic System (October 25, 2019)
  • 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)
  • 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)
  • K983465 — THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LIN (November 18, 1998)

FDA data resources