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510(k) K930142

SYNELISA U1-SNRNP (68KDA)-ANTIBODIES by Elias U.S.A., Inc. — Product Code LKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1993
Date Received
January 12, 1993
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 Elias U.S.A., Inc.

  • K964385 — ELIAS ANA-HEP-2 (March 6, 1997)
  • K963291 — VARELISA ANA (4) PROFILE (September 30, 1996)
  • K953873 — VARELISA HELICOBACTER PYLORI ANTIBODIES (August 30, 1996)
  • K953587 — VARELISA MPO-ANCA (January 26, 1996)
  • K953586 — VARELISA PR3-ANCA (January 26, 1996)
  • K951187 — VARELISA CARDIOLIPIN ABS SCREEN (October 2, 1995)
  • K951205 — VARELISA ANA PROFILE (April 17, 1995)
  • K944334 — VARELISA COMBINED DNA ANTIBODIES EIA (April 17, 1995)
  • K951206 — VARELISA PARIETAL CELL ANTIBODIES (April 17, 1995)
  • K951186 — VARELISA ANA-4 SCREEN (April 17, 1995)

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)
  • 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)