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510(k) K935564

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1995
Date Received
November 18, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Other clearances by Sudormed, Inc.

  • K936135 — SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRAT (June 10, 1996)
  • K936240 — SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE) (March 19, 1996)
  • 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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