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510(k) K020226

XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03 by Hellen Professional Services — Product Code JWZ

K020226 is an FDA 510(k) premarket notification submitted by Hellen Professional Services for the device "XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03". The FDA issued a decision of Substantially Equivalent on August 22, 2002. The device falls under product code JWZ (Kit, Screening, Trichomonas), a Class I device regulated under 21 CFR 866.2660. Hellen Professional Services has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2002
Date Received
January 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 by Hellen Professional Services

  • K981536 — QUANTECH MYOGLOBIN ASSAY (June 29, 1998)

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)
  • 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