Primus Corp.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Primus Corp.” (first 1989, latest 2007), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 106 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | 9 | 9 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 2 | 2 |
| GKA | Abnormal Hemoglobin Quantitation | 1 | 1 |
| JIS | Calibrator, Primary | 1 | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
Review panels
- Hematology (10)
- Clinical Chemistry (2)
- Immunology (2)
Most recent Primus Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K062658 | PRIMUS A1CARE ASSAY | LCP | 2007-11-26 | 446 |
| K013787 | NYCOCARD CRP | DCK | 2002-05-14 | 181 |
| K014084 | NYCOCARD CRP CONTROL | DCK | 2002-01-07 | 27 |
| K993131 | NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY | LCP | 2000-05-22 | 245 |
| K994045 | PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 | LCP | 1999-12-21 | 22 |
| K992921 | PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II | LCP | 1999-11-12 | 74 |
| K955283 | PRIMUS VARIANT SYSTEM PVS99 | GKA | 1996-03-01 | 106 |
| K942009 | PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY | LCP | 1994-09-14 | 142 |
| K940008 | GLYCATED PROTEIN CALIBRATORS | JIS | 1994-05-09 | 125 |
| K940142 | GLYCATED PROTEIN CONTROLS | JJX | 1994-04-26 | 105 |
4 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2020-10-09.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Primus Gloves Private , Ltd. (4 510(k)s)
- Primus Sterilizer Company, LLC (4 510(k)s)
- Primus Gloves Pvt Limited (3 510(k)s)
- Primus Sterilizer Co., Inc. (2 510(k)s)
- Primus Consulting (1 510(k)s)
- Primus Corporation Dba Trinity Biotech (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Primus Corp.?
FDA lists 14 510(k) clearances under the applicant name “Primus Corp.” (first 1989, latest 2007), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Primus Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Primus Corp. is 106 days.
Which FDA product codes appear under Primus Corp.?
The most frequent FDA product codes under this applicant name are LCP (Assay, Glycosylated Hemoglobin, 9); DCK (C-Reactive Protein, Antigen, Antiserum, And Control, 2); GKA (Abnormal Hemoglobin Quantitation, 1).
Next steps
- See all 14 Primus Corp. clearances with predicates and recalls
- Run predicate analysis for product code LCP, Primus Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.