Chrono-Log
Chrono-log Whole Blood Aggregometer (WBA)
1manufacturer
10catalogue numbers in this listing
6510(k) clearances naming this product code
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
Record
| Listed by | Chrono-LOG Corp., United States |
|---|---|
| FDA product code | JOZ |
| Device type | System, Automated Platelet Aggregation |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5700 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K962426 |
| Record published | 2016-10-11 |
| Record revised | 2022-09-16 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 592 | In distribution | |
| 591A | In distribution | |
| 592A | In distribution | |
| 490 4+4 | In distribution | |
| 700 | In distribution | |
| 700 | In distribution | |
| 592A | In distribution | |
| 592 | In distribution | |
| 490 4+ | In distribution | |
| 591 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| VerifyNow System | Accriva Diagnostics, Inc. | 12 |
| TEG6s Hemostasis System | Haemonetics Corporation | 5 |
| VerifyNow Platelet Reactivity Test | Accriva Diagnostics, Inc. | 4 |
| TEG Hemostasis System | Haemonetics Corporation | 3 |
| TEG5000 Hemostasis System | Haemonetics Corporation | 3 |
| AggRecetin | Bio/Data Corp. | 2 |
| Aggreguide | Aggredyne, Inc. | 2 |
| Plateletworks Combo-25 Kit | Helena Laboratories, Corp. | 1 |
| Epinephrine | Bio/Data Corp. | 1 |
| Bapa tube | Zacros Corporation | 1 |
| T-TAS 01 Total Thrombus Formation Analysis System | Zacros Corporation | 1 |
| PL Chip for T-TAS 01 | Zacros Corporation | 1 |
Showing 12 of 34. All products under System, Automated Platelet Aggregation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161329 | 2016-12-02 |
| K050265 | 2005-10-14 |
| K032951 | 2004-04-02 |
| K962426 | 1996-10-22 |
| K940792 | 1994-10-13 |
| K781807 | 1978-11-22 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.