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510(k) K030211

RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016 by Icn Biomedicals, Inc. — Product Code DKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2003
Date Received
January 21, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thin Layer Chromatography, Barbiturate
Device Class
Class II
Regulation Number
862.3150
Review Panel
TX
Submission Type

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  • K913963 — IMMUCHEM NEONATAL TSH-MP ELISA (December 13, 1991)
  • K902445 — LYMPHO SEP(TM) (August 22, 1990)
  • K885198 — 17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA (February 23, 1989)
  • K881005 — IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG (May 27, 1988)

Other clearances for product code DKX

  • K800364 — ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202 (March 12, 1980)