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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name enzyme linked immunoabsorbent assay, (chlamydiae group)
510(k) Number K903765
Device Name QUIDEL CHLAMYDIA POSITIVE CONTROL
Applicant
QUIDEL CORP.
10165 MCKELLAR COURT
SAN DIEGO,  CA  92121
Applicant Contact CRAIG E WATSON
Correspondent
QUIDEL CORP.
10165 MCKELLAR COURT
SAN DIEGO,  CA  92121
Correspondent Contact CRAIG E WATSON
Regulation Number866.3120
Classification Product Code
LJC  
Date Received08/17/1990
Decision Date 10/02/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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