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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
510(k) Number K922482
Device Name MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL
Applicant
Baxter Diagnostics, Inc.
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Applicant Contact SHARON K CULLEN
Correspondent
Baxter Diagnostics, Inc.
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Correspondent Contact SHARON K CULLEN
Regulation Number866.1640
Classification Product Code
LRG  
Date Received05/27/1992
Decision Date 03/12/1993
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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