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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K862048
Device Name SUDS(HCG)CONTROL SET (URINE&SERUM) & HCG REF.SERUM
Applicant
Murex Corp.
P.O. Noc 2003
Norcross,  GA  30091
Applicant Contact MARSHALL, PHD
Correspondent
Murex Corp.
P.O. Noc 2003
Norcross,  GA  30091
Correspondent Contact MARSHALL, PHD
Regulation Number870.1330
Classification Product Code
DQX  
Date Received05/29/1986
Decision Date 06/19/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
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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