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510(k) K021006

STARTOX DRUG OF ABUSE SCREENING TEST by Starplex Scientific, Inc. — Product Code DKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2002
Date Received
March 28, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

Other clearances by Starplex Scientific, Inc.

  • K032246 — MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM (August 13, 2003)
  • K022388 — STARTOX DRUG OF ABUSE SCREENING TEST (4) (February 27, 2003)
  • K962843 — MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM (September 18, 1996)
  • K960997 — STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM (April 3, 1996)
  • K944847 — KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM (February 16, 1995)
  • K924364 — VACUPLUS TUBES WITH GREY STOPPERS (March 1, 1993)
  • K924361 — VACUPLUS TUBES WITH GREEN STOPPERS (March 1, 1993)
  • K924362 — VACUPLUS TUBES WITH LAVANDER STOPPERS (March 1, 1993)
  • K924363 — VACUPLUS(R) STAR-SEP(TM) (February 8, 1993)
  • K924365 — VACUPLUS TUBES WITH BRICK RED STOPPERS (December 28, 1992)

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