FDA device listing
Multichem IA Plus 05P76-10,Multichem IA Plus, IA310A, IA311A, IA312A, IA313A,
FDA device listing 1586067681 · Techno-path Manufacturing Ltd.
Key facts
| Proprietary names | Multichem IA Plus 05P76-10,Multichem IA Plus, IA310A, IA311A, IA312A, IA313A, |
|---|---|
| Owner/operator | Techno-path Manufacturing Ltd. |
| Owner/operator number | 10030933 |
| Premarket submissions | K132091 |
| Product codes | JJY |
| Device names | JJY - Multi-Analyte Controls, All Kinds (Assayed) |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1660 |
| Review panels | Clinical Chemistry |
| Registered establishments | TECHNO-PATH MANUFACTURING LTD. |
| Establishment registrations | 3008156187 |
| FEI numbers | 3008156187 |
| Establishment operations | Foreign Exporter, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database