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510(k) K884170

ANALYST THEOPHYLLINE CALIBRATOR by The DU Pont Co. — Product Code DLJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1988
Date Received
September 21, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Specific
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
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)
  • K884700 — ANALYST THYROXINE (T4) ROTOR (January 27, 1989)
  • K884169 — DU PONT ANALYST THYROID ROTOR (January 24, 1989)

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