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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 K851098
Device Name BEHRING VECTOR PHOTOMETER
Applicant
Behring Diagnostics, Inc.
10933 No Torrey Pines Rd.
La Jolla,  CA  92037
Applicant Contact JOHN E HUGHES
Correspondent
Behring Diagnostics, Inc.
10933 No Torrey Pines Rd.
La Jolla,  CA  92037
Correspondent Contact JOHN E HUGHES
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received03/19/1985
Decision Date 04/25/1985
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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