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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

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

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  • K852665 — SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY (August 13, 1985)
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