Quantimetrix Corp.: FDA filings under this applicant name
FDA lists 39 510(k) clearances under the applicant name “Quantimetrix Corp.” (first 1983, latest 2016), across 18 product codes in 3 review panels. Median 510(k) review time under this name: 67 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 | 1 | 195 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 239 |
| 2016 | 1 | 266 |
| 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 7 | 7 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 6 | 6 |
| DIF | Drug Mixture Control Materials | 5 | 5 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 3 | 3 |
| CEK | Biuret (Colorimetric), Total Protein | 2 | 2 |
| JHO | Electrophoretic Separation, Lipoproteins | 2 | 2 |
| JJR | Electrolyte Controls (Assayed And Unassayed) | 2 | 2 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 2 | 2 |
| CJW | Bromcresol Purple Dye-Binding, Albumin | 1 | 1 |
| DIJ | Lead, Delta Amino Levulinic Acid | 1 | 1 |
Plus 8 more product codes.
Review panels
- Clinical Chemistry (27)
- Clinical Toxicology (10)
- Hematology (2)
Most recent Quantimetrix Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K152117 | Dropper hsCRP High Sensitivity CRP Control | JJX | 2016-04-21 | 266 |
| K142262 | AUTION CHECK PLUS | JJW | 2015-04-10 | 239 |
| K113177 | COMPLETE D 25-OH VITAMIN D CONTROL | JJX | 2012-05-10 | 195 |
| K103744 | DROPPER A1C DIABETES CONTROL | JJX | 2011-05-12 | 140 |
| K062942 | QUANTIMETRIX NICOSURE COTININE URINE CONTROL | LAS | 2006-10-30 | 32 |
| K062751 | MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER | JJT | 2006-10-03 | 19 |
| K060417 | MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL | DIF | 2006-03-21 | 32 |
| K032791 | GLYCOHEMOSURE HBA1C CONTROL | GGM | 2003-10-30 | 52 |
| K030826 | PRECISET DAT AMPHETAMINE | DIJ | 2003-04-03 | 20 |
| K021393 | PRECISET DAT PLUS | DKB | 2002-06-13 | 42 |
29 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2017-12-21.
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.
- Quantimetrix Medical Industries (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Quantimetrix Corp.?
FDA lists 39 510(k) clearances under the applicant name “Quantimetrix Corp.” (first 1983, latest 2016), across 18 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 Quantimetrix Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Quantimetrix Corp. is 67 days.
Which FDA product codes appear under Quantimetrix Corp.?
The most frequent FDA product codes under this applicant name are JJY (Multi-Analyte Controls, All Kinds (Assayed), 7); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 6); DIF (Drug Mixture Control Materials, 5).
Next steps
- See all 39 Quantimetrix Corp. clearances with predicates and recalls
- Run predicate analysis for product code JJY, Quantimetrix 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.