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510(k) K874259

TRICHOMONAS DIRECT ENZYME IMMUNOASSAY by California Integrated Diagnostics, Inc. — Product Code JWZ

K874259 is an FDA 510(k) premarket notification submitted by California Integrated Diagnostics, Inc. for the device "TRICHOMONAS DIRECT ENZYME IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on December 7, 1987. The device falls under product code JWZ (Kit, Screening, Trichomonas), a Class I device regulated under 21 CFR 866.2660. California Integrated Diagnostics, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1987
Date Received
October 20, 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

Other clearances by California Integrated Diagnostics, Inc.

  • K904095 — HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING (February 1, 1991)
  • K871279 — MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT (April 8, 1987)
  • K871278 — MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT (April 8, 1987)

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)
  • K875138 — TRICHOMATE(R) SUPER (May 13, 1988)
  • 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