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510(k) K840241

THYROXINE EMIA by Collaborative Research, Inc. — Product Code KLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1984
Date Received
January 20, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Device Class
Class II
Regulation Number
862.1700
Review Panel
CH
Submission Type

Other clearances by Collaborative Research, Inc.

  • K841541 — SERUM COMPLEMENT ACTIVITY TEST-SCAT (June 1, 1984)

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