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510(k) K811725

TBG DIAGNOSTIC KIT by Immuno Assay Corp. — Product Code CEF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1981
Date Received
June 18, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrophoretic, Protein Fractionation
Device Class
Class I
Regulation Number
862.1630
Review Panel
CH
Submission Type

Other clearances by Immuno Assay Corp.

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  • K820074 — CORTISOL (RIA) KIT (January 28, 1982)
  • K811954 — COMBO-FER IRON DIAGNOSTIC (July 27, 1981)
  • K811213 — T3 (RIA) KIT (May 29, 1981)
  • K811212 — DIGOXIN (RIA) KIT (May 21, 1981)
  • K810857 — T3 UPTAKE KIT (April 8, 1981)
  • K810811 — T4 RIA KIT (April 7, 1981)

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