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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
510(k) Number K924006
Device Name BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY
Applicant
Baxter Healthcare Corp
2005 NW Sammamish Rd.
Suite 107
Issauah,  WA  98027
Applicant Contact NANCY MALLINAK
Correspondent
Baxter Healthcare Corp
2005 NW Sammamish Rd.
Suite 107
Issauah,  WA  98027
Correspondent Contact NANCY MALLINAK
Regulation Number866.3330
Classification Product Code
GNX  
Date Received08/10/1992
Decision Date 12/29/1992
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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