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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase
510(k) Number K873625
Device Name CHEMELIA ENZYME IMMUNOASSAY FOR (TSH)
Applicant
Boots-Celltech Diagnostics, Inc.
240 Bath Rd.
Slough Sl1 4et
Berkshire, England,  GB
Applicant Contact JOHN SIMPSON
Correspondent
Boots-Celltech Diagnostics, Inc.
240 Bath Rd.
Slough Sl1 4et
Berkshire, England,  GB
Correspondent Contact JOHN SIMPSON
Regulation Number864.7360
Classification Product Code
JLM  
Date Received09/08/1987
Decision Date 10/20/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
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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