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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 K931907
Device Name ANTHOS HT READERS, INCLUDING THE ANTHOS HT II&III
Applicant
Anthos Labtec Instruments
C/O Hogan & Hartson
555 Thirteenth St., NW
Washington,  DC  20004
Applicant Contact PATRICIA B SHRADER
Correspondent
Anthos Labtec Instruments
C/O Hogan & Hartson
555 Thirteenth St., NW
Washington,  DC  20004
Correspondent Contact PATRICIA B SHRADER
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received04/15/1993
Decision Date 09/29/1993
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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