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510(k) K902055

TENONE(TM) OPIATES CATALOG: VKSO1,4 by Diagnostic Products Corp. — Product Code DDE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1990
Date Received
May 7, 1990
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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  • K021206 — IMMULITE 2000 SPECIFIC ALLERGENS (May 30, 2002)

Other clearances for product code DDE

  • K823680 — COAT-A-COUNT MORPHINE KIT & COMPONENTS (January 5, 1983)
  • K820900 — EMIT URINE METHADONE ASSAY #3E319 (April 26, 1982)