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510(k) K910411

MICROZYME TSH ENZYME IMMUNOASSAY KIT by Immunotech Corp. — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1991
Date Received
January 29, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Thyroid-Stimulating Hormone
Device Class
Class II
Regulation Number
862.1690
Review Panel
CH
Submission Type

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