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510(k) K945125

DUPONT ACA VANCOMYCIN (VANC) METHOD by The DU Pont Co. — Product Code LEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1995
Date Received
October 19, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Vancomycin
Device Class
Class II
Regulation Number
862.3950
Review Panel
TX
Submission Type

Other clearances by The DU Pont Co.

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  • K952891 — CRONEX LOW ABSORPTION CASSETTE (July 13, 1995)
  • 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)
  • K884168 — ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA. (November 29, 1988)

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