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510(k) K780146

T3 STI KIT by Polysciences, Inc. — Product Code KHQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 1978
Date Received
January 30, 1978
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

Other clearances by Polysciences, Inc.

  • K923349 — FUNGI FLUOR KIT (October 20, 1992)
  • K871290 — CENTRICELL(TM) (August 5, 1987)

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  • K954807 — CEDIA T UPTAKE ASSAY (December 21, 1995)
  • K951586 — T-UPTAKE EIA TEST (May 15, 1995)
  • K933414 — STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY (November 22, 1994)
  • K934312 — AXSYM(TM) T-UPTAKE (June 21, 1994)
  • K935816 — VIDAS T UPTAKE (March 22, 1994)