510(k)
K083222: AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100
FDA 510(k) · Axis-Shield Diagnostics, Ltd. · decided Jul 31, 2009
Key facts
| 510(k) number | K083222 |
|---|---|
| Device name | AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 |
| Applicant | Axis-Shield Diagnostics, Ltd. |
| Product code | LPS |
| Subsequent product codes | JIT |
| Date received | Nov 3, 2008 |
| Decision date | Jul 31, 2009 |
| Decision | Substantially equivalent (SESE) |
| Submission type | Traditional |
| Review panel | Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
At a glance
- None MAUDE adverse event reports
- 1–9 Recall events
- 1–9 UDI device identifiers (GUDID)
- 1–9 Predicate devices cited
- 1–9 Later submissions citing this device
- 10–99 510(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: