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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Follicle-Stimulating Hormone
510(k) Number K872309
Device Name MICROMEDIC COMBOSTAT LH/FSH KIT
Applicant
Micromedic Systems
102 Witmer Rd.
Horsham,  PA  19044
Applicant Contact DEBORAH L LINDEMUTH
Correspondent
Micromedic Systems
102 Witmer Rd.
Horsham,  PA  19044
Correspondent Contact DEBORAH L LINDEMUTH
Regulation Number862.1300
Classification Product Code
CGJ  
Date Received06/16/1987
Decision Date 07/31/1987
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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