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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K934521
Device Name SPQ MALB CONTROL LEVEL II
Applicant
Incstar Corp.
1990 Insustrial Blvd.
P.O. Box 285
Stillwater,  MN  55082
Applicant Contact MARY ELLEN BEST
Correspondent
Incstar Corp.
1990 Insustrial Blvd.
P.O. Box 285
Stillwater,  MN  55082
Correspondent Contact MARY ELLEN BEST
Regulation Number862.1660
Classification Product Code
JJX  
Date Received09/17/1993
Decision Date 11/26/1993
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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