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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K844082
Device Name QUEST BETA HCG ENZYME IMMUNOASSAY KIT
Applicant
Quidel Corp.
11077 N. Torrey Pines Rd.
La Jolla,  CA  92037
Applicant Contact ALBERT B SNYDER
Correspondent
Quidel Corp.
11077 N. Torrey Pines Rd.
La Jolla,  CA  92037
Correspondent Contact ALBERT B SNYDER
Regulation Number862.1155
Classification Product Code
JHI  
Date Received10/19/1984
Decision Date 11/21/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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