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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone
510(k) Number K883726
Device Name THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL
Applicant
Immuchem Corp.
P.O. Box 6227
2015 E. University Dr.
Carson,  CA  90746
Applicant Contact J BURNS
Correspondent
Immuchem Corp.
P.O. Box 6227
2015 E. University Dr.
Carson,  CA  90746
Correspondent Contact J BURNS
Regulation Number862.1690
Classification Product Code
JLW  
Date Received08/31/1988
Decision Date 12/15/1988
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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