Company ยท US
Primus Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 2007. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 26, 2007 | K062658 | PRIMUS A1CARE ASSAY Primus Corp. | LCP |
| May 14, 2002 | K013787 | NYCOCARD CRP Primus Corp. | DCK |
| Jan 7, 2002 | K014084 | NYCOCARD CRP CONTROL Primus Corp. | DCK |
| May 22, 2000 | K993131 | NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY Primus, Inc. | LCP |
| Dec 21, 1999 | K994045 | PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 Primus Corp. | LCP |
| Nov 12, 1999 | K992921 | PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II Primus Corp. | LCP |
| Mar 1, 1996 | K955283 | PRIMUS VARIANT SYSTEM PVS99 Primus Corp. | GKA |
| Sep 14, 1994 | K942009 | PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY Primus Corp. | LCP |
| May 9, 1994 | K940008 | GLYCATED PROTEIN CALIBRATORS Primus Corp. | JIS |
| Apr 26, 1994 | K940142 | GLYCATED PROTEIN CONTROLS Primus Corp. | JJX |
| Mar 22, 1994 | K936204 | GLYCATED HEMOGLOBIN CALIBRATORS Primus Corp. | LCP |
| Mar 15, 1994 | K940143 | GLYCATED HEMOGLOBIN CONTROLS Primus Corp. | LCP |
| Jun 28, 1990 | K896582 | DIABETES CARE(TM) TEST PACKAGE FOR THE CLC 330(TM) Primus, Inc. | LCP |
| Jun 16, 1989 | K891235 | PRIMUS MODEL CLC 330 Primus, Inc. | LCP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2020 | Primus Corporation Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation Terminated |
GKA | K955283 |