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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 K850708
Device Name SPECTRONIC 1001 - CLINICAL SPECTROPHOTOMETER
Applicant
Bausch & Lomb, Inc.
1400 N. Goodman St.
P.O.Box 450
Rochester,  NY  14692
Applicant Contact NICHOLAS A WALP
Correspondent
Bausch & Lomb, Inc.
1400 N. Goodman St.
P.O.Box 450
Rochester,  NY  14692
Correspondent Contact NICHOLAS A WALP
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received02/22/1985
Decision Date 03/11/1985
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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