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510(k) K936135

SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATION by Sudormed, Inc. — Product Code LAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1996
Date Received
December 28, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Cannabinoid(S)
Device Class
Class II
Regulation Number
862.3870
Review Panel
TX
Submission Type

Other clearances by Sudormed, Inc.

  • K936240 — SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE) (March 19, 1996)
  • K935564 — SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATIO (July 14, 1995)
  • K926253 — SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE (July 14, 1995)
  • K935588 — SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF AMPHETAMINES IN PERSPI (July 14, 1995)
  • K902442 — SUDORMED SWEAT PATCH SPECIMEN CONTAINER (October 4, 1990)

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  • K961620 — ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100 (June 13, 1996)
  • K914507 — DOUBLE ANTIBODY CANNABIONOIDS/QUAIL DETER IN URINE (December 18, 1991)
  • K913414 — ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT (September 25, 1991)
  • K913865 — URINE THC DIRECT RIA KIT (I-125) (September 18, 1991)
  • K912574 — ABUSCREEN ONLINE FOR THC (50 AND 100) (August 12, 1991)
  • K904996 — ABUSCREEN ONLINE TM FOR THC (January 11, 1991)
  • K843534 — ORAL THC-CANNABINOIDS DIRECT RIA KIT (October 30, 1984)
  • K833911 — URINE THC CANNABINOIDS DIRECT RIA KIT (January 24, 1984)
  • K821965 — ORAL THC-CANNABINOIDS DIRECT RIA KIT (July 20, 1982)