510(k)
K001900: ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST
FDA 510(k) · Helix Diagnostics, Inc. · decided Sep 11, 2000
Key facts
| 510(k) number | K001900 |
|---|---|
| Device name | ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST |
| Applicant | Helix Diagnostics, Inc. |
| Product code | LRM |
| Date received | Jun 22, 2000 |
| Decision date | Sep 11, 2000 |
| Decision | Substantially equivalent (SESE) |
| Submission type | Traditional |
| Review panel | Immunology |
| Medical specialty | Immunology |
At a glance
- None MAUDE adverse event reports
- None Recall events
- 1–9 UDI device identifiers (GUDID)
- None Predicate devices cited
- None Later submissions citing this device
- 10–99 510(k)s with this product code
- No 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: