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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 K903934
Device Name GEN-PROBE LUMINOMETER-LEADER 50
Applicant
Gen-Probe, Inc.
9880 Campus Pt. Dr.
San Diego,  CA  92121
Applicant Contact CHAIREZ, PH.D.
Correspondent
Gen-Probe, Inc.
9880 Campus Pt. Dr.
San Diego,  CA  92121
Correspondent Contact CHAIREZ, PH.D.
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received08/27/1990
Decision Date 09/27/1990
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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