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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, total thyroxine
510(k) Number K915235
Device Name CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT
Applicant
INCSTAR CORP.
1990 INSUSTRIAL BLVD.
P.O. BOX 285
STILLWATER,  MN  55082 -0285
Applicant Contact ELLEN BEST
Correspondent
INCSTAR CORP.
1990 INSUSTRIAL BLVD.
P.O. BOX 285
STILLWATER,  MN  55082 -0285
Correspondent Contact ELLEN BEST
Regulation Number862.1700
Classification Product Code
CDX  
Date Received11/22/1991
Decision Date 01/28/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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