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510(k) K973153

UBI MAGIWEL AMPHETAMINE METABOLITES by United Biotech, Inc. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1997
Date Received
August 22, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

Other clearances by United Biotech, Inc.

  • K981573 — UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE (September 15, 1998)
  • K973154 — UBI MAGIWEL MARIJUANA METABOLITES (July 22, 1998)
  • K973692 — UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE (February 9, 1998)
  • K973155 — UBI MAGIWEL OPIATE METABOLITES (October 28, 1997)
  • K973156 — UBI MAGIWEL COCAINE METABOLITES (October 28, 1997)
  • K962211 — UBI MAGIWEL THYROXINE (T4) QUANTITATIVE (July 8, 1996)
  • K961236 — UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE (May 30, 1996)
  • K951993 — UBI MAGIWEL FERRITIN QUANTITATIVE (July 5, 1995)
  • K924689 — UBI MAGIWEL(TM) HELICOBACTER PYLORI IGG (August 10, 1993)
  • K905473 — UBI MAGIWEL CORTISOL QUANTITATIVE (January 31, 1991)

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