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510(k) K941146

DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM by Dupont Medical Products — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1994
Date Received
March 10, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Thyroid-Stimulating Hormone
Device Class
Class II
Regulation Number
862.1690
Review Panel
CH
Submission Type

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  • K945280 — DUPONT DIMENSION C-REACTIVE PROTEIN METHOD (March 9, 1995)
  • K944932 — PHENOBARBITAL FLEX REAGENT CARTRIDGE (December 28, 1994)
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  • K943996 — DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD (October 20, 1994)
  • K942640 — DUPONT DIMENSION AMYLASE METHOD (September 9, 1994)
  • K942241 — DUPONT APC BLOOD COLLECTION CONTAINER WITH THROMBOPLASTIN (August 18, 1994)

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