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510(k) K910697

IL THEOPHYLLINE ASSAY SYSTEM by Instrumentation Laboratory CO — Product Code KLS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1991
Date Received
February 19, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Theophylline
Device Class
Class II
Regulation Number
862.3880
Review Panel
TX
Submission Type

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Other clearances for product code KLS

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  • K993029 — ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89 (January 27, 2000)
  • K973583 — ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS (November 12, 1997)
  • K972495 — ACCUMETER THEOPHYLLINE TEST (October 10, 1997)
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