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510(k) K951206

VARELISA PARIETAL CELL ANTIBODIES by Elias U.S.A., Inc. — Product Code MLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1995
Date Received
March 17, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
Device Class
Class II
Regulation Number
866.5110
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)
  • K951186 — VARELISA ANA-4 SCREEN (April 17, 1995)
  • K951207 — VARELISA HISTONE ANTIBODIES (April 17, 1995)

Other clearances for product code MLE

  • K010558 — QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA (April 3, 2001)
  • K991942 — AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA (August 24, 1999)