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510(k) K822808

TDX KENAMYCIN by Abbott Laboratories — Product Code KJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 1982
Date Received
September 17, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Kanamycin
Device Class
Class II
Regulation Number
862.3520
Review Panel
TX
Submission Type

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Other clearances for product code KJI

  • K832769 — AMES TDA KANAMYCIN TEST-CONTROL SERUM (September 29, 1983)
  • K823370 — ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY (December 3, 1982)
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  • K782125 — RIA KIT, KANAMYCIN (January 10, 1979)
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