Abaxis, Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Abaxis, Inc.” (first 1994, latest 2021), across 15 product codes in 2 review panels. Median 510(k) review time under this name: 76 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 | 2 | 50 |
| 2013 | 2 | 36 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 567 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Abaxis, Inc. took a median 567 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 234 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 3 | 3 |
| JGJ | Photometric Method, Magnesium | 2 | 2 |
| JGY | Colorimetric Method, Triglycerides | 2 | 2 |
| JJG | Analyzer, Chemistry, Centrifugal, For Clinical Use | 2 | 2 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 | 1 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 1 | 1 |
| DCN | System, Test, C-Reactive Protein | 1 | 1 |
| JGS | Electrode, Ion Specific, Sodium | 1 | 1 |
| JHM | Colorimetric Method, Lipoproteins | 1 | 1 |
Plus 5 more product codes.
Review panels
- Clinical Chemistry (19)
- Immunology (1)
Most recent Abaxis, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200865 | Piccolo Potassium Test System | MZV | 2021-10-20 | 567 |
| K130113 | PICCOLO LACTATE TEST SYSTEM | KHP | 2013-03-11 | 54 |
| K130200 | PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM | CHH | 2013-02-15 | 18 |
| K120664 | PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM | JGY | 2012-04-24 | 50 |
| K120662 | PICCOLO HDL-CAPILLARY TEST SYSTEM | JHM | 2012-04-24 | 50 |
| K091052 | PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM | DCN | 2010-01-15 | 277 |
| K091910 | PICCOLO MAGNESIUM TEST SYSTEM | JGJ | 2009-10-01 | 98 |
| K051108 | PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM | CFJ | 2005-07-08 | 67 |
| K040115 | PICCOLO MAGNESIUM TEST SYSTEM | JGJ | 2004-01-30 | 10 |
| K023642 | PICCOLO TOTAL CHOLESTEROL TEST SYSTEM | CHH | 2003-01-24 | 86 |
10 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2019-12-11.
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 Abaxis, Inc.?
FDA lists 20 510(k) clearances under the applicant name “Abaxis, Inc.” (first 1994, latest 2021), across 15 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 Abaxis, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Abaxis, Inc. is 76 days.
Which FDA product codes appear under Abaxis, Inc.?
The most frequent FDA product codes under this applicant name are CHH (Enzymatic Esterase--Oxidase, Cholesterol, 3); JGJ (Photometric Method, Magnesium, 2); JGY (Colorimetric Method, Triglycerides, 2).
Next steps
- See all 20 Abaxis, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CHH, Abaxis, 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.