FDA device listing
BAPA tube,BAPA Tube for T-TAS 01,PL Chip,PL Chip for T-TAS 01,PL Chip Reservoir set,PL Chip Reservoir Set for T-TAS…
FDA device listing 1400994138 · ZACROS CORPORATION
Key facts
| Proprietary names | BAPA tube,BAPA Tube for T-TAS 01,PL Chip,PL Chip for T-TAS 01,PL Chip Reservoir set,PL Chip Reservoir Set for T-TAS 01,T-TAS 01 Total Thrombus Formation Analysis System Instrument |
|---|---|
| Owner/operator | ZACROS CORPORATION |
| Owner/operator number | 10062628 |
| Premarket submissions | K191364 |
| Product codes | JOZ |
| Device names | JOZ - System, Automated Platelet Aggregation |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.5700 |
| Review panels | Hematology |
| Registered establishments | ZACROS CORPORATION, ZACROS CORPORATION MIE FACILITY |
| Establishment registrations | 3016571810, 3017875469 |
| FEI numbers | 3016571810, 3017875469 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, Specification Developer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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