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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 K854303
Device Name MR 700 MICROPLATE READER 012-700-1000
Applicant
Dynatech Laboratories, Inc.
900 Slaters Ln.
Alexandria,  VA  22314
Applicant Contact HEIDI E CHANDONNET
Correspondent
Dynatech Laboratories, Inc.
900 Slaters Ln.
Alexandria,  VA  22314
Correspondent Contact HEIDI E CHANDONNET
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received10/25/1985
Decision Date 11/19/1985
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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