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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 K881458
Device Name ASTROSCAN 2100 MICROTITER PLATE READER
Applicant
Astroscan , Ltd.
Finch House, 42 Finch Rd.
Douglas, Isle Of Man
Biritish Isles, England,  GB
Applicant Contact WENDY JOHNSON
Correspondent
Astroscan , Ltd.
Finch House, 42 Finch Rd.
Douglas, Isle Of Man
Biritish Isles, England,  GB
Correspondent Contact WENDY JOHNSON
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received04/07/1988
Decision Date 06/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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