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Primus Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
14
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K062658PRIMUS A1CARE ASSAYNovember 26, 2007
K013787NYCOCARD CRPMay 14, 2002
K014084NYCOCARD CRP CONTROLJanuary 7, 2002
K993131NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAYMay 22, 2000
K994045PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2December 21, 1999
K992921PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL IINovember 12, 1999
K955283PRIMUS VARIANT SYSTEM PVS99March 1, 1996
K942009PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAYSeptember 14, 1994
K940008GLYCATED PROTEIN CALIBRATORSMay 9, 1994
K940142GLYCATED PROTEIN CONTROLSApril 26, 1994
K936204GLYCATED HEMOGLOBIN CALIBRATORSMarch 22, 1994
K940143GLYCATED HEMOGLOBIN CONTROLSMarch 15, 1994
K896582DIABETES CARE(TM) TEST PACKAGE FOR THE CLC 330(TM)June 28, 1990
K891235PRIMUS MODEL CLC 330June 16, 1989