Quantimetrix Medical Industries: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Quantimetrix Medical Industries” (first 1986, latest 1989), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 48 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 |
|---|---|---|---|
| JJT | Enzyme Controls (Assayed And Unassayed) | 2 | 2 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 | 2 |
| DIF | Drug Mixture Control Materials | 1 | 1 |
| JIS | Calibrator, Primary | 1 | 1 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | 1 |
| LAS | Drug Specific Control Materials | 1 | 1 |
Review panels
Most recent Quantimetrix Medical Industries 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K895778 | QUANTIMETRIX BILIRUBIN CALIBRATORS | JIS | 1989-11-14 | 48 |
| K883395 | ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY | JJT | 1988-09-19 | 39 |
| K883247 | LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL | JJY | 1988-09-13 | 42 |
| K874302 | QUANTIMETRIX TOTAL CREATINE KINASE CONTROL | JJT | 1988-02-02 | 105 |
| K874890 | QUANTIMETRIX URINE DIPSTICK CONTROL | JJW | 1988-01-21 | 51 |
| K873011 | QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2 | LAS | 1987-10-29 | 86 |
| K873467 | QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL | DIF | 1987-09-29 | 32 |
| K861448 | QUANTIMETRIX SERUM LIPID CONTROL I & II LIQUID | JJY | 1986-04-28 | 47 |
Recalls
openFDA lists no recalls under a recalling firm named Quantimetrix Medical Industries.
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 Corp. (39 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Quantimetrix Medical Industries?
FDA lists 8 510(k) clearances under the applicant name “Quantimetrix Medical Industries” (first 1986, latest 1989), across 6 product codes in 2 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 Medical Industries?
The median time from FDA receipt to decision across 510(k)s cleared under the name Quantimetrix Medical Industries is 48 days.
Which FDA product codes appear under Quantimetrix Medical Industries?
The most frequent FDA product codes under this applicant name are JJT (Enzyme Controls (Assayed And Unassayed), 2); JJY (Multi-Analyte Controls, All Kinds (Assayed), 2); DIF (Drug Mixture Control Materials, 1).
Next steps
- See all 8 Quantimetrix Medical Industries clearances with predicates and recalls
- Run predicate analysis for product code JJT, Quantimetrix Medical Industries'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.