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510(k) K884700

ANALYST THYROXINE (T4) ROTOR by The DU Pont Co. — Product Code KLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1989
Date Received
November 9, 1988
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

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  • K943704 — LIPASE CALIBRATOR (September 14, 1994)
  • K900492 — LABELING CHANGE - VIASPAN(TM) (BELZER UW) (March 20, 1990)
  • K885259 — ACA THYRONINE UPTAKE (TU E) METHOD (February 17, 1989)
  • K885258 — ACA THYROXINE (T4 E) METHOD (February 17, 1989)
  • K884169 — DU PONT ANALYST THYROID ROTOR (January 24, 1989)
  • K884168 — ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA. (November 29, 1988)

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