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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Microtiter Diluting/Dispensing
510(k) Number K901808
Device Name MICROMATE 196 MODEL A961960
Applicant
Packard Instrument Co., Inc.
2200 Warrenville Rd.
Downers Grove,  IL  60515
Applicant Contact DOROTHY MRKVICKA
Correspondent
Packard Instrument Co., Inc.
2200 Warrenville Rd.
Downers Grove,  IL  60515
Correspondent Contact DOROTHY MRKVICKA
Regulation Number866.2500
Classification Product Code
JTC  
Date Received04/20/1990
Decision Date 06/20/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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