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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 K920160
Device Name LH GEN III SELF-TEST/CONCEIVE
Applicant
QUIDEL CORP.
10165 MCKELLAR COURT
SAN DIEGO,  CA  92121
Applicant Contact JOHN D TAMERIUS
Correspondent
QUIDEL CORP.
10165 MCKELLAR COURT
SAN DIEGO,  CA  92121
Correspondent Contact JOHN D TAMERIUS
Regulation Number862.1485
Classification Product Code
CEP  
Date Received01/14/1992
Decision Date 03/11/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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