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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prealbumin, Fitc, Antigen, Antiserum, Control
510(k) Number K934966
Device Name SPQ PAL CONTROL LEVEL II
Applicant
INCSTAR CORP.
1990 INSUSTRIAL BLVD.
P.O. BOX 285
STILLWATER,  MN  55082 -0285
Applicant Contact MARY ELLEN BEST
Correspondent
INCSTAR CORP.
1990 INSUSTRIAL BLVD.
P.O. BOX 285
STILLWATER,  MN  55082 -0285
Correspondent Contact MARY ELLEN BEST
Regulation Number866.5060
Classification Product Code
DDS  
Date Received10/15/1993
Decision Date 01/11/1994
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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