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510(k) K991597

COBAS INTEGRA AMIKACIN MAB by Roche Diagnostics Corp. — Product Code LGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1999
Date Received
May 10, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescence Polarization Immunoassay, Amibacin
Device Class
Class II
Regulation Number
862.3035
Review Panel
TX
Submission Type

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Other clearances for product code LGJ

  • K941712 — COBAS-FP REAGENTS AND CALIBRATORS (June 13, 1994)
  • K862248 — AMIKACIN KIT (FPIA) (August 4, 1986)