Company ยท US
Waters Assoc., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1981. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KIE | Apparatus, High Pressure Liquid Chromatography | 4 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 2 |
| BZL | Computer, Oxygen-Uptake | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| DSF | Recorder, Paper Chart | 1 |
| DXM | Densitometer | 1 |
| DYG | Catheter, Flow Directed | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 |
| KHO | Fluorometer, For Clinical Use | 1 |
| KRB | Probe, Thermodilution | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 27, 1981 | K811975 | MODEL 480 VARIABLE WAVELENGTH ULTRA VIOL Waters Assoc., Inc. | JJQ |
| Oct 31, 1980 | K802481 | 7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH Waters Assoc., Inc. | DYG |
| Aug 20, 1980 | K801852 | MRM-2 OXYGEN CONSUMPTION MONITOR Waters Assoc., Inc. | BZL |
| Aug 12, 1980 | K801431 | PAN-AM MYELOGRAM TRAY Waters Assoc., Inc. | FMI |
| Sep 24, 1979 | K791661 | SYSTEM CONTROLLER 720 SERIES Waters Assoc., Inc. | KIE |
| Jun 22, 1979 | K791026 | 4F STERILE BALLOON-LESS, CATHETER 913-28 Waters Assoc., Inc. | KRB |
| Feb 15, 1979 | K790145 | SOLVENT DELIVERY SYSTEM Waters Assoc., Inc. | KIE |
| Feb 15, 1979 | K782175 | CARTRIDGE HOLDER, RCM 100 Waters Assoc., Inc. | KIE |
| Jan 29, 1979 | K781805 | CARDIAC COMPUTERS, CO-10 & CO-10R Waters Assoc., Inc. | DXG |
| Jan 10, 1979 | K781915 | DATA MODULE Waters Assoc., Inc. | KIE |
| Nov 29, 1978 | K781692 | CALIBRATOR, DYNAMIC Waters Assoc., Inc. | DXM |
| Sep 20, 1978 | K781264 | PAB CONVENIENCE TRAY Waters Assoc., Inc. | GAA |
| Mar 27, 1978 | K780245 | RECORDER, RE-100P HOT STYLUS STRIP CHART Waters Assoc., Inc. | DSF |
| Jan 20, 1978 | K780031 | FLUORESCENCE DETECTOR MODEL 420 Waters Assoc., Inc. | KHO |
| Jan 12, 1978 | K772311 | WISP MODEL 710 Waters Assoc., Inc. | CHH |
| Dec 9, 1976 | K761166 | TC-1 CARDIAC OUTPUT COMPUTER Waters Assoc., Inc. | DXG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||