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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 K991998
Device Name GAMMA-B 25-HYDROXY VITAMIN D RIA
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 Received06/14/1999
Decision Date 09/17/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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