Jas Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Jas Diagnostics, Inc.” (first 2000, latest 2014), across 19 product codes in 2 review panels. Median 510(k) review time under this name: 58 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 | 1 | 408 |
| 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 |
|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | 2 | 2 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CFR | Hexokinase, Glucose | 1 | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 | 1 |
| CJY | Azo Dye, Calcium | 1 | 1 |
Plus 9 more product codes.
Review panels
- Clinical Chemistry (19)
- Hematology (1)
Most recent Jas Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130915 | XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK | JJE | 2014-05-15 | 408 |
| K080623 | CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA | CHH | 2008-11-17 | 257 |
| K080618 | DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID | LCP | 2008-05-23 | 79 |
| K022519 | LDL CHOLESTEROL (AUTOMATED) | JHM | 2002-09-30 | 62 |
| K021671 | JAS HDL CHOLESTEROL (AUTOMATED) REAGENT | LBS | 2002-07-19 | 59 |
| K020454 | CHEMISTRY CALIBRATOR | JIT | 2002-04-08 | 56 |
| K020282 | JAS AMYLASE LIQUID REAGENT | JFJ | 2002-02-28 | 31 |
| K013912 | CREATINE KINASE (CK-NAC) | CGS | 2002-01-18 | 52 |
| K013698 | AST (SGOT) | CIT | 2001-12-21 | 44 |
| K012332 | JAS CARBON DIOXIDE LIQUID REAGENT | KHS | 2001-09-06 | 45 |
10 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2017-04-21.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Jas Diagnostics, Inc.?
FDA lists 20 510(k) clearances under the applicant name “Jas Diagnostics, Inc.” (first 2000, latest 2014), across 19 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 Jas Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Jas Diagnostics, Inc. is 58 days.
Which FDA product codes appear under Jas Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are CIG (Diazo Colorimetry, Bilirubin, 2); CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus, 1); CFR (Hexokinase, Glucose, 1).
Next steps
- See all 20 Jas Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CIG, Jas Diagnostics, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.