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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 K892213
Device Name ACS COLLOID OSMOTIC PRESSURE CALIBRATOR
Applicant
Analytical Control Systems, Inc.
9001 Technology Dr.
Suite A
Fishers,  IN  46060
Applicant Contact PAULINE W BONDERMAN
Correspondent
Analytical Control Systems, Inc.
9001 Technology Dr.
Suite A
Fishers,  IN  46060
Correspondent Contact PAULINE W BONDERMAN
Regulation Number862.1150
Classification Product Code
JIW  
Date Received04/03/1989
Decision Date 06/21/1989
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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