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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K042307
Device Name ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH)
Applicant
Seradyn, Inc.
7998 Georgetown Rd.
Suite 1000
Indianapolis,  IN  46268
Applicant Contact JACK ROGERS
Correspondent
Seradyn, Inc.
7998 Georgetown Rd.
Suite 1000
Indianapolis,  IN  46268
Correspondent Contact JACK ROGERS
Regulation Number862.1150
Classification Product Code
JIT  
Subsequent Product Code
JJX  
Date Received08/25/2004
Decision Date 11/03/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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