Teledyne Analytical Instruments
City Industry, CA, US
Teledyne Analytical Instruments appears in FDA device records in City Industry, CA. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Teledyne Analytical Instruments carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Teledyne Instruments - Analytical Instrumentsrecall
510(k) clearance history
FDA records hold 3 510(k) clearances for Teledyne Analytical Instruments between 2000 and 2003. The busiest year on record is 2003, with 2. The most recent is 2003, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2003 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K024228 | RX300 OXYGEN ANALYZER | CCL | Substantially Equivalent | |
| K024155 | MX 300 OXYGEN MONITOR | CCL | Substantially Equivalent | |
| K001095 | OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130 | CCL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2026424 | 2026424 | Teledyne Analytical Instruments | a business unit of Teledyne Instruments, Inc., City Industry, CA 91748 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3001-2011 | Micro-Fuel Cell Oxygen Sensor, Class RI5 Sensor Part Number: C41131-R15 Teledyne Instruments - Analytical Instruments Disposable oxygen sensors with limited useful life. These sensors are accessories to other oxygen diagnostic devices, and are not in themselves suitable for therapeutic use. | The recall was initiated because during a test on a batch of sensors on the company shipping dock, Teledyne Instruments discovered electrolyte loss from the sealing cylinder on a few sensors. This test was done pursuant to a complaint from one customer of label discoloration caused because of the electrolyte loss. The risk of a leak form the oxygen sensor while in use is the disruption of therape | Terminated | ||
| Z-0145-04 | Portable Oxygen Analyzer | Potential failure to display the battery low light to the end-user. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain