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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Prolactin (Lactogen)
510(k) Number K843804
Device Name TANDEM - EPRL
Applicant
Hybritech, Inc.
11085 Torreyana Rd.
San Diego,  CA  92126
Applicant Contact JOHN F BRUNI
Correspondent
Hybritech, Inc.
11085 Torreyana Rd.
San Diego,  CA  92126
Correspondent Contact JOHN F BRUNI
Regulation Number862.1625
Classification Product Code
CFT  
Date Received09/27/1984
Decision Date 11/13/1984
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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