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FDA 510(k) Application Details - K971269
Device Classification Name
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
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510(K) Number
K971269
Device Name
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Applicant
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
445 MEDICAL CENTER BLVD.
WEBSTER, TX 77598 US
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Contact
JOHN WILLIS
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Regulation Number
862.1700
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Classification Product Code
KLI
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More FDA Info for this Product Code
Date Received
04/04/1997
Decision Date
05/22/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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