Beckman-Diagnostic Systems Group: FDA clearances and approvals
Beckman-Diagnostic Systems Group has 11 FDA 510(k) clearances (first 1993, latest 1994), across 11 product codes in 3 review panels. Median 510(k) review time: 79 days.
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 |
|---|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 | 1 |
| DFT | Igm, Antigen, Antiserum, Control | 1 | 1 |
| DJG | Enzyme Immunoassay, Opiates | 1 | 1 |
| DKC | Alcohol Control Materials | 1 | 1 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 | 1 |
| JFJ | Catalytic Methods, Amylase | 1 | 1 |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | 1 | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | 1 |
| KHP | Acid, Lactic, Enzymatic Method | 1 | 1 |
Plus 1 more product codes.
Review panels
- Clinical Chemistry (6)
- Clinical Toxicology (4)
- Immunology (1)
Most recent Beckman-Diagnostic Systems Group 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K945522 | I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS | DFT | 1994-12-12 | 32 |
| K944605 | CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM | LCM | 1994-12-07 | 79 |
| K944604 | CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMS | DKZ | 1994-12-07 | 79 |
| K944606 | CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS | DJG | 1994-11-30 | 72 |
| K942676 | SYNCHRON CX3 DELTA | JJF | 1994-11-02 | 149 |
| K934293 | BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT | JFJ | 1994-07-06 | 307 |
| K934068 | BECKMAN DIRECT BILIRUBIN REAGENT | CIG | 1994-04-26 | 249 |
| K936184 | VIGIL PRX CHEMISTRY CONTROL | JJY | 1994-04-15 | 109 |
| K934271 | BECKMAN SYNCHRON LACTATE REAGENT | KHP | 1993-11-09 | 70 |
| K934046 | BECKMAN CHOLESTEROL REAGENT | CHH | 1993-10-28 | 70 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Beckman-Diagnostic Systems Group.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Beckman-Diagnostic Systems Group have?
Beckman-Diagnostic Systems Group has 11 FDA 510(k) clearances (first 1993, latest 1994), across 11 product codes in 3 review panels.
How long does FDA take to clear Beckman-Diagnostic Systems Group's 510(k)s?
The median time from FDA receipt to decision across Beckman-Diagnostic Systems Group's cleared 510(k)s is 79 days.
What devices does Beckman-Diagnostic Systems Group make?
Its most frequent FDA product codes are CHH (Enzymatic Esterase--Oxidase, Cholesterol, 1); CIG (Diazo Colorimetry, Bilirubin, 1); DFT (Igm, Antigen, Antiserum, Control, 1).
Has Beckman-Diagnostic Systems Group had device recalls?
openFDA lists no recalls under a recalling firm name matching Beckman-Diagnostic Systems Group. Related entities may recall under other names.
Next steps
- See all 11 Beckman-Diagnostic Systems Group clearances with predicates and recalls
- Run predicate analysis for product code CHH, Beckman-Diagnostic Systems Group's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.