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510(k) K883765

TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE by Biotecx Laboratories, Inc. — Product Code KHQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1988
Date Received
September 6, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioassay, Triiodothyronine Uptake
Device Class
Class II
Regulation Number
862.1715
Review Panel
CH
Submission Type

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  • K851540 — ESTRADIOL DIRECT RIA KIT (June 6, 1985)
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  • K933414 — STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY (November 22, 1994)
  • K934312 — AXSYM(TM) T-UPTAKE (June 21, 1994)
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