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510(k) K875138

TRICHOMATE(R) SUPER by Mercia Diagnostics , Ltd. — Product Code JWZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1988
Date Received
December 15, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Screening, Trichomonas
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

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  • K896194 — CAPTIA(R) CMV-G (March 6, 1990)
  • K896295 — CAPTIA(R) CMV-M (March 6, 1990)
  • K900655 — MODIFIED CAPTIA(R) TOXO-M (March 6, 1990)
  • K885300 — CAPTIA(R) RUBELLA-M (August 15, 1989)
  • K883924 — CAPTIA(R) RUBELLA-G (August 15, 1989)
  • K892802 — SUPER DUO (June 13, 1989)
  • K881425 — CAPTIA(R) SYPHILIS-G (August 4, 1988)

Other clearances for product code JWZ

  • K033864 — GENZYME OSOM TRICHOMONAS RAPID TEST (April 2, 2004)
  • K020595 — XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01 (February 20, 2003)
  • K020226 — XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 (August 22, 2002)
  • K894246 — MERIVIEW TM TRICHOMONAS (August 15, 1989)
  • K892802 — SUPER DUO (June 13, 1989)
  • K892263 — MERIFLUOR(TM) -TRICHOMONAS (May 24, 1989)
  • K874259 — TRICHOMONAS DIRECT ENZYME IMMUNOASSAY (December 7, 1987)
  • K871279 — MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT (April 8, 1987)
  • K852665 — SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY (August 13, 1985)
  • K830497 — PEM-T (April 5, 1983)