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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 K873408
Device Name MODEL 690 SPECTROPHOTOMETER
Applicant
Abbott Diagnostics
850 Maude Ave.
Mountain View,  CA  94043
Applicant Contact ALAN B FOWLER
Correspondent
Abbott Diagnostics
850 Maude Ave.
Mountain View,  CA  94043
Correspondent Contact ALAN B FOWLER
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received08/25/1987
Decision Date 09/08/1987
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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