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510(k) K830497

PEM-T by Hedeco — Product Code JWZ

K830497 is an FDA 510(k) premarket notification submitted by Hedeco for the device "PEM-T". The FDA issued a decision of Substantially Equivalent on April 5, 1983. The device falls under product code JWZ (Kit, Screening, Trichomonas), a Class I device regulated under 21 CFR 866.2660. Hedeco has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1983
Date Received
February 16, 1983
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 Hedeco

  • K822380 — ROMBEAU GASTROSTOMY-JEJUNAL TUBE (September 17, 1982)
  • K820063 — KEOFEED 500 ENTERIC FEEDING PUMP (February 10, 1982)
  • K812507 — THE KEOFEED STOMACH TUBE (September 14, 1981)

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)
  • 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)

FDA data resources