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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
Date
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elecsys dhea-s calset Roche Diagnostics Corp. k002760 10/05/2000
modification to integra reagent cassette for hemoglobin a1c Roche Diagnostics Corp. k003120 12/18/2000
accuwarm emg heat lamp Rjl Associates, LLC k001800 09/12/2000
knight endoscopic spine system (kess) Richard Wolf Medical Instruments Corp. k000046 03/30/2000
rhigene mesacup2 test- ssa Rhigene, Inc. k000749 05/09/2000
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
lifecard cf compact recorder Reynolds Medical , Ltd. k001025 04/19/2000
retrax retracting needle syringe, size 3cc Retrax Safety Systems, Inc. k001017 06/02/2000

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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