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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Fibrinogen Determination
510(k) Number K900939
Device Name SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.)
Applicant
Incstar Corp.
1990 Insustrial Blvd.
P.O. Box 285
Stillwater,  MN  55082
Applicant Contact JOHN G YAGER
Correspondent
Incstar Corp.
1990 Insustrial Blvd.
P.O. Box 285
Stillwater,  MN  55082
Correspondent Contact JOHN G YAGER
Regulation Number864.7340
Classification Product Code
KQJ  
Date Received02/28/1990
Decision Date 05/16/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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