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510(k) K823680

COAT-A-COUNT MORPHINE KIT & COMPONENTS by Diagnostic Products Corp. — Product Code DDE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1983
Date Received
December 7, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Carbonic Anhydrase C, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5200
Review Panel
HE
Submission Type

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  • K021257 — ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) (June 3, 2002)
  • K021206 — IMMULITE 2000 SPECIFIC ALLERGENS (May 30, 2002)

Other clearances for product code DDE

  • K902055 — TENONE(TM) OPIATES CATALOG: VKSO1,4 (July 10, 1990)
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