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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name visual, pregnancy hcg, prescription use
510(k) Number K863861
Device Name TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA
Applicant
HYBRITECH, INC.
11095 TORREYANA RD.
P.O. BOX 269006
SAN DIEGO,  CA  92126
Applicant Contact BRUNI, PH.D.
Correspondent
HYBRITECH, INC.
11095 TORREYANA RD.
P.O. BOX 269006
SAN DIEGO,  CA  92126
Correspondent Contact BRUNI, PH.D.
Regulation Number862.1155
Classification Product Code
JHI  
Date Received10/03/1986
Decision Date 11/21/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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