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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 K852411
Device Name MR 650 MICROPLATE READER(CAT. NO. 011-973-0500)
Applicant
Dynatech Laboratories, Inc.
900 Slaters Ln.
Alexandria,  VA  22314
Applicant Contact RICHARD K PRESCOTT
Correspondent
Dynatech Laboratories, Inc.
900 Slaters Ln.
Alexandria,  VA  22314
Correspondent Contact RICHARD K PRESCOTT
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received06/06/1985
Decision Date 09/30/1985
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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