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510(k) K892802

SUPER DUO by Mercia Diagnostics , Ltd. — Product Code JWZ

K892802 is an FDA 510(k) premarket notification submitted by Mercia Diagnostics , Ltd. for the device "SUPER DUO". The FDA issued a decision of Substantially Equivalent on June 13, 1989. The device falls under product code JWZ (Kit, Screening, Trichomonas), a Class I device regulated under 21 CFR 866.2660. Mercia Diagnostics , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1989
Date Received
April 17, 1989
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 Mercia Diagnostics , Ltd.

  • K915479 — CAPTIA CMV-TA (May 4, 1992)
  • K904524 — CAPTIA(R) SYPHILIS M, MODIFICATION (December 26, 1990)
  • K900654 — MODIFIED CAPTIA(R) SYPHILIS-M (March 8, 1990)
  • K900655 — MODIFIED CAPTIA(R) TOXO-M (March 6, 1990)
  • K896194 — CAPTIA(R) CMV-G (March 6, 1990)
  • K896295 — CAPTIA(R) CMV-M (March 6, 1990)
  • K885300 — CAPTIA(R) RUBELLA-M (August 15, 1989)
  • K883924 — CAPTIA(R) RUBELLA-G (August 15, 1989)
  • K881425 — CAPTIA(R) SYPHILIS-G (August 4, 1988)
  • K880918 — CAPTIA TOXO-G (August 1, 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)
  • 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