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510(k) K020595

XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01 by Xenotope Diagnostics, Inc. — Product Code JWZ

K020595 is an FDA 510(k) premarket notification submitted by Xenotope Diagnostics, Inc. for the device "XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01". The FDA issued a decision of Substantially Equivalent on February 20, 2003. The device falls under product code JWZ (Kit, Screening, Trichomonas), a Class I device regulated under 21 CFR 866.2660.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2003
Date Received
February 22, 2002
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

Other clearances for product code JWZ

  • K033864 — GENZYME OSOM TRICHOMONAS RAPID TEST (April 2, 2004)
  • 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)
  • K875138 — TRICHOMATE(R) SUPER (May 13, 1988)
  • 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)

FDA data resources