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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, luteinizing hormone
510(k) Number K943996
Device Name DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD
Applicant
DUPONT MEDICAL PRODUCTS
331 TREBLE COVE RD.
N. BILLERICA,  MA  01862
Applicant Contact REBRCCA AYASH
Correspondent
DUPONT MEDICAL PRODUCTS
331 TREBLE COVE RD.
N. BILLERICA,  MA  01862
Correspondent Contact REBRCCA AYASH
Regulation Number862.1485
Classification Product Code
CEP  
Date Received08/16/1994
Decision Date 10/20/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
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