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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometer
510(k) Number K862674
Device Name PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM
Applicant
Hybritech, Inc.
11095 Torreyana Rd.
P.O. Box 269006
San Diego,  CA  92126
Applicant Contact BRUNI, PHD
Correspondent
Hybritech, Inc.
11095 Torreyana Rd.
P.O. Box 269006
San Diego,  CA  92126
Correspondent Contact BRUNI, PHD
Regulation Number866.4520
Classification Product Code
JZT  
Date Received07/14/1986
Decision Date 08/15/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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