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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 K852146
Device Name QUIDEL QUEST OVULATION TEST
Applicant
QUIDEL CORP.
11077 NORTH TORREY PINES RD.
LA JOLLA,  CA  92037
Applicant Contact ALBERT B SNYDER
Correspondent
QUIDEL CORP.
11077 NORTH TORREY PINES RD.
LA JOLLA,  CA  92037
Correspondent Contact ALBERT B SNYDER
Regulation Number862.1485
Classification Product Code
CEP  
Date Received05/16/1985
Decision Date 07/29/1985
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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