Medical Device Manufacturer · US , Kansas City , MO

Primus Corp. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 1994

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Primus Corp. Hematology ✕

8 devices

1-8 of 8

Cleared Dec 21, 1999

PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2

Hematology · 22d

Cleared Nov 12, 1999

PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II

Hematology · 74d

Cleared Mar 01, 1996

PRIMUS VARIANT SYSTEM PVS99

Hematology · 106d

Cleared Sep 14, 1994

PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY

Hematology · 142d

Cleared May 09, 1994

GLYCATED PROTEIN CALIBRATORS

Hematology · 125d

Cleared Apr 26, 1994

GLYCATED PROTEIN CONTROLS

Hematology · 105d

Cleared Mar 22, 1994

GLYCATED HEMOGLOBIN CALIBRATORS

Hematology · 83d

Cleared Mar 15, 1994

GLYCATED HEMOGLOBIN CONTROLS

Hematology · 63d