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510(k) K842167

TBG RIA by Syncor Intl. Corp. — Product Code CEE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1984
Date Received
May 31, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Thyroxine-Binding Globulin
Device Class
Class II
Regulation Number
862.1685
Review Panel
CH
Submission Type

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  • K885034 — T-UPTAKE MICROASSAY (February 2, 1989)
  • K884201 — FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT (December 14, 1988)
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