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510(k) K945607

VARELISA M2 ANTIBODIES by Elias U.S.A., Inc. — Product Code DBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1995
Date Received
November 15, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5090
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 DBM

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  • K163525 — QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT (September 5, 2017)
  • K163133 — ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Anti (August 8, 2017)
  • K141375 — ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 (February 13, 2015)
  • K092736 — EUROIMMUN ANTI-M2-3E ELISA (IGG) (September 2, 2010)
  • K052262 — QUANTA LITE M2 EP (MIT3) ELISA (October 27, 2005)
  • K031308 — RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 (September 26, 2003)
  • K030238 — BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT (March 24, 2003)
  • K982121 — ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT (September 17, 1998)
  • K971909 — VIRGO AMA ELISA KIT (June 20, 1997)