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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 K902776
Device Name SPECTROPHOTOMETER (MICROASSAY PLATE READERS)
Applicant
Slt Labinstruments, Inc.
164 Dimmocks Mill Rd.
P.O. Box 8101
Hillsborough,  NC  27278
Applicant Contact DAVID L JURANAS
Correspondent
Slt Labinstruments, Inc.
164 Dimmocks Mill Rd.
P.O. Box 8101
Hillsborough,  NC  27278
Correspondent Contact DAVID L JURANAS
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received06/25/1990
Decision Date 07/31/1990
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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