Abx Diagnostics: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Abx Diagnostics” (first 1999, latest 2003), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 44 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 |
|---|---|---|---|
| GKZ | Counter, Differential Cell | 9 | 9 |
| GKX | Instrument, Automated Platelet Counting | 1 | 1 |
Review panels
- Hematology (10)
Most recent Abx Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K030799 | MICROS 60 | GKZ | 2003-04-08 | 26 |
| K030144 | MODIFICATION TO PENTRA 60 AND PENTRA 60C+ | GKZ | 2003-01-31 | 16 |
| K024002 | PENTRA 80 | GKZ | 2003-01-03 | 30 |
| K022200 | PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120 | GKZ | 2002-07-29 | 24 |
| K014203 | ABX MICROS 60 HEMATOLOGY ANALYZER | GKX | 2002-02-28 | 69 |
| K003677 | ABX PENTRA 60C+ HEMATOLOGY ANALYZER | GKZ | 2000-12-26 | 27 |
| K002646 | ABX MICROS CRP | GKZ | 2000-10-26 | 63 |
| K992511 | ABX PENTRA 60 HEMATOLOGY ANALYZER | GKZ | 1999-10-15 | 80 |
| K991839 | ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER | GKZ | 1999-08-11 | 75 |
| K990311 | VEGA RETIC AUTOMATED HEMATOLOGY ANALYZER | GKZ | 1999-03-31 | 58 |
Recalls
6 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2006-03-24.
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 Abx Diagnostics?
FDA lists 10 510(k) clearances under the applicant name “Abx Diagnostics” (first 1999, latest 2003), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Abx Diagnostics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Abx Diagnostics is 44 days.
Which FDA product codes appear under Abx Diagnostics?
The most frequent FDA product codes under this applicant name are GKZ (Counter, Differential Cell, 9); GKX (Instrument, Automated Platelet Counting, 1).
Next steps
- See all 10 Abx Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code GKZ, Abx Diagnostics'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.