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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nephelometer
510(k) Number K873407
Device Name RRT SYSTEM LASER REFLECTOMETER ANALYZER
Applicant
Incstar Corp.
1990 Insustrial Blvd.
P.O. Box 285
Stillwater,  MN  55082
Applicant Contact LISA J STONE
Correspondent
Incstar Corp.
1990 Insustrial Blvd.
P.O. Box 285
Stillwater,  MN  55082
Correspondent Contact LISA J STONE
Regulation Number866.4540
Classification Product Code
JZW  
Date Received08/25/1987
Decision Date 09/23/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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