Company ยท US
Waters Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2007. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JQW | Station, Pipetting And Diluting, For Clinical Use | 1 |
| KIE | Apparatus, High Pressure Liquid Chromatography | 1 |
| KZR | Chromatography (Liquid, Gel), Clinical Use | 1 |
| LDM | Instrumentation, High Pressure Liquid Chromatography | 1 |
| LEQ | Detectors, Electrochemical, Liquid Chromatography | 1 |
| MLM | Enzyme Immunoassay, Tracrolimus | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 25, 2007 | K063868 | MASSTRAK IMMUNOSUPPRESSANTS KIT Waters Corporation | MLM |
| Feb 12, 1998 | K980180 | 2700 SAMPLE MANAGER Waters Corporation | JQW |
| Oct 6, 1997 | K973074 | 2487 DUAL WAVELENGTH ABSORBANCE DETECTOR Waters Corporation | KZR |
| Nov 29, 1996 | K964588 | WATERS 515 HPLC PUMP (515) Waters Corporation | KIE |
| Jul 22, 1996 | K962574 | WATERS 474 SCANNING FLOURESCENCE DETECTOR (474) Waters Corporation | LEQ |
| Jul 5, 1996 | K961557 | ALLIANCE 2690 SEPARATIONS MODULE Waters Corporation | LDM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||