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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid Phosphatase (Prostatic), Tartrate Inhibited
510(k) Number K851950
Device Name TANDEM E PAP
Applicant
HYBRITECH, INC.
11095 TORREYANA RD.
P.O. BOX 269006
SAN DIEGO,  CA  92126
Applicant Contact JOHN F BRUNI
Correspondent
HYBRITECH, INC.
11095 TORREYANA RD.
P.O. BOX 269006
SAN DIEGO,  CA  92126
Correspondent Contact JOHN F BRUNI
Regulation Number862.1020
Classification Product Code
JFH  
Date Received05/03/1985
Decision Date 06/25/1985
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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