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510(k) K930422

SYNELISA PARIETAL CELL ANTIBODIES by Elias U.S.A., Inc. — Product Code DBJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1993
Date Received
January 26, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiparietal Antibody, Indirect Immunofluorescent, 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)
  • K951206 — VARELISA PARIETAL CELL ANTIBODIES (April 17, 1995)
  • K951186 — VARELISA ANA-4 SCREEN (April 17, 1995)

Other clearances for product code DBJ

  • K790759 — IIF-APCA TEST KIT (July 30, 1979)