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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Surgical, Needle
510(k) Number K772188
Device Name FSH RIA KIT (125I)
Applicant
DIAGNOSTIC PRODUCTS CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
DIAGNOSTIC PRODUCTS CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4800
Classification Product Code
FSH  
Date Received11/25/1977
Decision Date 12/22/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
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