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510(k) K820900

EMIT URINE METHADONE ASSAY #3E319 by Syva Co. — Product Code DDE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1982
Date Received
March 31, 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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  • K993986 — SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL (January 27, 2000)
  • K993985 — SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL (January 27, 2000)

Other clearances for product code DDE

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