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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Device, Specimen Collection
510(k) Number K003761
Device Name NAT - NUCLEIC ACID TRANSPORT
Applicant
Medical Packaging Corp.
941 Avenida Acaso
Camarillo,  CA  93012
Applicant Contact RICHARD CURTIS
Correspondent
Medical Packaging Corp.
941 Avenida Acaso
Camarillo,  CA  93012
Correspondent Contact RICHARD CURTIS
Regulation Number866.2900
Classification Product Code
LIO  
Date Received12/06/2000
Decision Date 05/31/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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