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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Glycosylated Hemoglobin
510(k) Number K050178
Device Name HBA1C ENZYMATIC ASSAY
Applicant
General Atomics
3550 General Atomics Court
San Diego,  CA  92121
Applicant Contact HUAN TRAN
Correspondent
General Atomics
3550 General Atomics Court
San Diego,  CA  92121
Correspondent Contact HUAN TRAN
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Codes
JIS   JJX  
Date Received01/26/2005
Decision Date 06/28/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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