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510(k) K953873

VARELISA HELICOBACTER PYLORI ANTIBODIES by Elias U.S.A., Inc. — Product Code LYR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1996
Date Received
August 17, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Helicobacter Pylori
Device Class
Class I
Regulation Number
866.3110
Review Panel
MI
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)
  • 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)
  • K951207 — VARELISA HISTONE ANTIBODIES (April 17, 1995)

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  • K181379 — H. PYLORI QUIK CHEK (August 21, 2018)
  • K181400 — H. PYLORI CHEK™ (August 21, 2018)
  • K161139 — LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set (July 22, 2016)
  • K153661 — ImmunoCard STAT! HpSA (March 14, 2016)