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510(k) K951122

CAPITOL URINE DRUG SCREEN COLLECTION KIT by Harry A. Schlakman — Product Code KDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1995
Date Received
February 27, 1995
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 by Harry A. Schlakman

  • K945480 — MOSS(R) STEEL BREAKAWAY(R) INTRODUCER (August 28, 1995)

Other clearances for product code KDW

  • K970580 — SASI-DC1TS (April 17, 1997)
  • K931474 — DRUG, INSURANCE, URINALYSIS, BLOOD/URINE TEST KITS (May 10, 1994)
  • K913967 — DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEM (October 18, 1991)