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510(k) K864409

IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS by Sclavo, Inc. — Product Code LER

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1986
Date Received
November 10, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K863475 — THEOFAST(TM) TEST PACKAGE (November 5, 1986)
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  • K831514 — AMWA TDA THEOPHYLLINE TEST (June 30, 1983)
  • K823576 — COBAS STANDARD FOR TOTAL PROTEIN (January 7, 1983)
  • K820397 — AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM (March 2, 1982)