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510(k) K970580

SASI-DC1TS by Substance Abuse Specialties, Inc. — Product Code KDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1997
Date Received
February 14, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Specimen Mailer And Storage, Temperature Controlled, Sterile
Device Class
Class I
Regulation Number
864.3250
Review Panel
PA
Submission Type

Other clearances for product code KDW

  • K951122 — CAPITOL URINE DRUG SCREEN COLLECTION KIT (May 5, 1995)
  • K931474 — DRUG, INSURANCE, URINALYSIS, BLOOD/URINE TEST KITS (May 10, 1994)
  • K913967 — DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEM (October 18, 1991)