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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, vitamin d
510(k) Number K042519
Device Name GAMMA-B 1,25-DIHYDROXY VITAMIN D
Applicant
IMMUNODIAGNOSTIC SYSTEMS LTD.
10 DIDCOT WAY,
BOLDEN BUSINESS PARK
BOLDON, TYNE & WEAR,  GB NE35 9PD
Applicant Contact PAUL PUNTIN
Correspondent
IMMUNODIAGNOSTIC SYSTEMS LTD.
10 DIDCOT WAY,
BOLDEN BUSINESS PARK
BOLDON, TYNE & WEAR,  GB NE35 9PD
Correspondent Contact PAUL PUNTIN
Regulation Number862.1825
Classification Product Code
MRG  
Date Received09/16/2004
Decision Date 12/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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