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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Luteinizing Hormone
510(k) Number K872131
Device Name TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY
Applicant
Hybritech, Inc.
11095 Torreyana Rd.
P.O. Box 269006
San Diego,  CA  92126
Applicant Contact CASAL, PHD
Correspondent
Hybritech, Inc.
11095 Torreyana Rd.
P.O. Box 269006
San Diego,  CA  92126
Correspondent Contact CASAL, PHD
Regulation Number862.1485
Classification Product Code
CEP  
Date Received06/04/1987
Decision Date 08/25/1987
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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