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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Parathyroid Hormone
510(k) Number K921629
Device Name N-TACT(R) PTH SP KIT
Applicant
INCSTAR CORP.
1990 INSUSTRIAL BLVD.
P.O. BOX 285
STILLWATER,  MN  55082 -0285
Applicant Contact MEREDITH G TALLAS
Correspondent
INCSTAR CORP.
1990 INSUSTRIAL BLVD.
P.O. BOX 285
STILLWATER,  MN  55082 -0285
Correspondent Contact MEREDITH G TALLAS
Regulation Number862.1545
Classification Product Code
CEW  
Date Received04/06/1992
Decision Date 05/14/1992
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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