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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K872219
Device Name GEN-PROBE (R) LUMINOMETER - LEADER (TM)
Applicant
Gen-Probe, Inc.
9880 Campus Pt. Dr.
San Diego,  CA  92121
Applicant Contact BRUNI, PH.D.
Correspondent
Gen-Probe, Inc.
9880 Campus Pt. Dr.
San Diego,  CA  92121
Correspondent Contact BRUNI, PH.D.
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received06/12/1987
Decision Date 08/21/1987
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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