510(k)
K050231: ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET
FDA 510(k) · Roche Diagnostics Corp. · decided Jul 6, 2005
Key facts
| 510(k) number | K050231 |
|---|---|
| Device name | ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET |
| Applicant | Roche Diagnostics Corp. |
| Product code | JIT |
| Subsequent product codes | NIG |
| Date received | Jan 26, 2005 |
| Decision date | Jul 6, 2005 |
| Decision | Substantially equivalent (SESE) |
| Submission type | Traditional |
| Review panel | Immunology |
| Medical specialty | Clinical Chemistry |
At a glance
- 100–999 MAUDE adverse event reports
- 1–9 Recall events
- 1–9 UDI device identifiers (GUDID)
- None Predicate devices cited
- 1–9 Later submissions citing this device
- 100–999 510(k)s with this product code
- Yes 510(k) summary on file
- No 510(k) statement on file
- Not listed On the FDA AI-enabled device list
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
Reading a 510(k)
- Decision
- SESE means the FDA found the device substantially equivalent to its predicate, so it may be marketed in the United States.
- Predicates
- Each clearance cites one or more legally marketed devices; the chain of predicates shows where a technology came from.
- Product code
- The three-letter code sets the device type, class and regulation, and groups competing clearances.
- Summary or statement
- Applicants file either a 510(k) summary of the safety and effectiveness information or a statement that it is available on request.
About 510(k) premarket notifications
A 510(k) is a premarket submission made to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.
Source: U.S. Food and Drug Administration (FDA), 510(k) Premarket Notification database · Source date: