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510(k) K933123

SYNELISA TG ANTIBODIES/TPO ANTIBODIES by Elias U.S.A., Inc. — Product Code JZS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1993
Date Received
June 28, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrophoresis Instrumentation
Device Class
Class I
Regulation Number
866.4500
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 JZS

  • K812194 — IMMUNODIFFUSION BAND INTENSIFYING FLUID (August 31, 1981)
  • K770566 — IMMUNOELECTROPHORESIS PROFILE KIT (April 27, 1977)
  • K770718 — STAIN, R-250, COOMASSIE BRILLIANT BLUE (April 26, 1977)
  • K770719 — IMMUNOELECTROFILM KIH (April 26, 1977)
  • K770150 — ELECTRO IMMUNO ASSAY KIT (February 1, 1977)