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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Surrogate
510(k) Number K852260
Device Name QUICK-CHEM CALIBRATION SET
Applicant
Seragen Diagnostics, Inc.
P.O. Box 1210
Indianapolis,  IN  46206
Applicant Contact MICHAEL J SULLIVAN
Correspondent
Seragen Diagnostics, Inc.
P.O. Box 1210
Indianapolis,  IN  46206
Correspondent Contact MICHAEL J SULLIVAN
Regulation Number862.1150
Classification Product Code
JIW  
Date Received05/24/1985
Decision Date 07/22/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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