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510(k) K941219

DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATOR by Dupont Medical Products — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1994
Date Received
March 14, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by Dupont Medical Products

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  • K952816 — LIPASE FLEX REAGENT CARTRIDGE (July 20, 1995)
  • K952412 — DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL (June 23, 1995)
  • K945280 — DUPONT DIMENSION C-REACTIVE PROTEIN METHOD (March 9, 1995)
  • K944932 — PHENOBARBITAL FLEX REAGENT CARTRIDGE (December 28, 1994)
  • K941050 — DUPONT ACA STAR (November 10, 1994)
  • K943996 — DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD (October 20, 1994)
  • K941146 — DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM (October 3, 1994)
  • K942640 — DUPONT DIMENSION AMYLASE METHOD (September 9, 1994)

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