K6460 Triple Quadrupole MS – AJS
Catalogue number K6460 Triple Quadrupole MS – AJS, listed by Agilent Technologies, Inc, United States, under Mass Spectrometer, Clinical Use. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
1recall
Who Else Makes It
All of them in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
Record
| Listed by | Agilent Technologies, Inc, United States |
|---|---|
| FDA product code | DOP |
| Device type | Mass Spectrometer, Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2860 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-08-15 |
| Record revised | 2022-09-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K6460 Triple Quadrupole MS → AJS | No Device Sizes | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Xevo | Waters Corporation | 6 |
| LCMS-8050 CL | Shimadzu Corp. | 3 |
| LCMS-8060 CL | Shimadzu Corp. | 2 |
| LCMS-8040 CL | Shimadzu Corp. | 2 |
| SpectroChip CPM Kit (2×96) | Agena Bioscience Incorporated | 1 |
| Triple Quad™ 4500MD | AB Sciex (Manufacturing) | 1 |
| Citrine Qtrap MS/MS | AB Sciex (Manufacturing) | 1 |
| TopazTM System | AB Sciex (Manufacturing) | 1 |
| cobas pro i 601 BL | Roche Diagnostics Gmbh | 1 |
| SpectroChip CPM Kit (10×96) | Agena Bioscience Incorporated | 1 |
| cobas i 601 SBL | Roche Diagnostics Gmbh | 1 |
| SpectroChip Standalone Chip Only) | Agena Bioscience Incorporated | 1 |
Showing 12 of 27. All products under Mass Spectrometer, Clinical Use
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-08-15 | Class II | Software design | When utilizing specific software versions of an LC/MS device, and Batch at a Glance in Compound Table view, a defect occurs when a new sample(s) is inserted. This defect creates a mismatch between the sample name and the column header where | 235 | 2021-09-28 |
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.