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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K922081
Device Name LABOTECH AUTOMATED MICROTITER ANALYZER
Applicant
Innovative Medical Systems, Inc.
P.O. Box 4450
Warren,  NJ  07060
Applicant Contact RAY ANDERSON
Correspondent
Innovative Medical Systems, Inc.
P.O. Box 4450
Warren,  NJ  07060
Correspondent Contact RAY ANDERSON
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received05/05/1992
Decision Date 09/02/1992
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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