Pointe Scientific, Inc.,: FDA filings under this applicant name
FDA lists 74 510(k) clearances under the applicant name “Pointe Scientific, Inc.,” (first 1981, latest 2007), across 42 product codes in 4 review panels. Median 510(k) review time under this name: 49 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 |
|---|---|---|---|
| CFR | Hexokinase, Glucose | 4 | 4 |
| CIG | Diazo Colorimetry, Bilirubin | 4 | 4 |
| JFJ | Catalytic Methods, Amylase | 4 | 4 |
| LCP | Assay, Glycosylated Hemoglobin | 4 | 4 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 3 | 3 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 3 | 3 |
| CIC | Cresolphthalein Complexone, Calcium | 3 | 3 |
| KHS | Enzymatic, Carbon-Dioxide | 3 | 3 |
| LBR | Ldl & Vldl Precipitation, Hdl | 3 | 3 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 2 | 2 |
Plus 32 more product codes.
Review panels
- Clinical Chemistry (65)
- Hematology (6)
- Immunology (2)
- Clinical Toxicology (1)
Most recent Pointe Scientific, Inc., 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K070757 | MICROPROTEIN REAGENT SET | JGP | 2007-12-04 | 259 |
| K062118 | POINTE 360 | CFR | 2007-07-13 | 353 |
| K070251 | CARBON DIOXIDE LIQUID STABLE REAGENT | KHS | 2007-04-30 | 94 |
| K070207 | MULTI-ANALYTE CHEMISTRY CALIBRATOR | JIX | 2007-04-13 | 81 |
| K070504 | AMMONIA/ALCOHOL CONTROL SET | JJY | 2007-04-11 | 49 |
| K061377 | APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS | MSJ | 2007-03-28 | 315 |
| K051646 | ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH | JGS | 2005-10-07 | 108 |
| K040391 | TOTAL BILIRUBIN REAGENT SET | CIG | 2004-06-02 | 106 |
| K031539 | HEMOGLOBIN A1C REAGENT SET | LCP | 2003-08-06 | 82 |
| K023860 | MICROALBUMIN REAGENT SET AND CALIBRATORS | DDZ | 2003-04-28 | 159 |
64 earlier clearances. See the full list in Caduvo.
Recalls
81 product recalls in 21 recall events; 0 initiated in the last five years. Most recent: 2015-05-19.
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.
- Pointe Conception Medical, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pointe Scientific, Inc.,?
FDA lists 74 510(k) clearances under the applicant name “Pointe Scientific, Inc.,” (first 1981, latest 2007), across 42 product codes in 4 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 Pointe Scientific, Inc.,?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pointe Scientific, Inc., is 49 days.
Which FDA product codes appear under Pointe Scientific, Inc.,?
The most frequent FDA product codes under this applicant name are CFR (Hexokinase, Glucose, 4); CIG (Diazo Colorimetry, Bilirubin, 4); JFJ (Catalytic Methods, Amylase, 4).
Next steps
- See all 74 Pointe Scientific, Inc., clearances with predicates and recalls
- Run predicate analysis for product code CFR, Pointe Scientific, Inc.,'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.