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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
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rhigene mesacup2 test- scl-70 RHIGENE, INC. k000750 05/09/2000
rhigene mesacup2 test- ssb RHIGENE, INC. k000751 05/09/2000
rhigene mesacup2 test- rnp RHIGENE, INC. k000752 05/09/2000
rhigene mesacup2 test- sm RHIGENE, INC. k000755 05/09/2000
rhigene ndna test system for imagetiter, model cl100l RHIGENE, INC. k011068 04/11/2002
espirt RESPIRONICS, INC. k001208 05/12/2000
profox software, model 920m-41 RESPIRONICS GEORGIA, INC. k001708 03/01/2001
retinadx REGULATORY ASSOCIATES, INC. k003236 11/02/2000
direct tibc kit REFERENCE DIAGNOSTICS, INC. k000781 05/02/2000
comfor-cliner RECLINER CARE, INC. k010194 02/15/2001

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