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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 K874262
Device Name LAD MODEL 735 LUMINOMETER
Applicant
Los Alamos Diagnostics
P.O. Box 1221
2470 E. Rd.
Los Alamos,  NM  87544
Applicant Contact BETTY STRIETELMEIER
Correspondent
Los Alamos Diagnostics
P.O. Box 1221
2470 E. Rd.
Los Alamos,  NM  87544
Correspondent Contact BETTY STRIETELMEIER
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received10/20/1987
Decision Date 11/27/1987
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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