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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 K020799
Device Name QUICKVUE ONE-STEP HCG-URINE
Applicant
QUIDEL CORP.
10165 MCKELLAR CT.
SAN DIEGO,  CA  92121
Applicant Contact JENNIFER S HANKARD
Correspondent
QUIDEL CORP.
10165 MCKELLAR CT.
SAN DIEGO,  CA  92121
Correspondent Contact JENNIFER S HANKARD
Regulation Number862.1155
Classification Product Code
JHI  
Date Received03/12/2002
Decision Date 05/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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