Company ยท US
Hamilton Co.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 1996. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
13recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JQW | Station, Pipetting And Diluting, For Clinical Use | 12 |
| JTC | Device, Microtiter Diluting/Dispensing | 7 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 2 |
| -JT | 1 | |
| DJY | Ion-Exchange Chromatography | 1 |
| DMZ | Liquid Chromatography, Adsorbent | 1 |
| DNH | Resins, Ion-Exchange, Liquid Chromatography | 1 |
| DPM | Columns, Liquid Chromatography | 1 |
| JJC | Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use | 1 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 |
| KZR | Chromatography (Liquid, Gel), Clinical Use | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 16, 1996 | K961896 | MICROLAB 4000, MICROLAB 4200 Hamilton Co. | JQW |
| Jan 30, 1995 | K943493 | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER Hamilton Co. | JJE |
| Jun 2, 1989 | K892369 | MULTI-PROBE HEAD PLUS Hamilton Co. | JTC |
| Jan 5, 1988 | K873893 | LUMICON Hamilton Co. | JJQ |
| May 29, 1987 | K871945 | MICROLAB AT Hamilton Co. | JTC |
| Aug 24, 1983 | K832205 | PRECISION LIQUID DISPENSER Hamilton Co. | JQW |
| Aug 24, 1983 | K832204 | MICROLAB P Hamilton Co. | JQW |
| Aug 24, 1983 | K832202 | PB 600 REPEATING DISPENSER Hamilton Co. | JQW |
| Aug 16, 1983 | K832201 | CHROM-PREP Hamilton Co. | KZR |
| Aug 16, 1983 | K832200 | PRP-1 REVERSED PHASE COLUMNS FOR HPLC Hamilton Co. | DPM |
| Aug 16, 1983 | K832199 | HC40/HC75 CATION EXCHANGE RESIN Hamilton Co. | DNH |
| Aug 12, 1983 | K832198 | HC40/HC75 PREPACKED COLUMS Hamilton Co. | DJY |
| Aug 12, 1983 | K832197 | PRP-1 REVERSED PHASE RESIN Hamilton Co. | DMZ |
| Aug 8, 1983 | K832203 | MULTI-TITER DISPENSER Hamilton Co. | JTC |
| Nov 5, 1982 | K822688 | DIGITAL DILUTER/DISPENSERS Hamilton Co. | JQW |
| Sep 26, 1980 | K801913 | MICROLAB M-MICROPROCESSOR DILUTER/DISP Hamilton Co. | JQW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2021 | Hamilton Co HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% - 85% no condensation. REF 19903400 Open, Classified |
JQW | None listed |
| Oct 21, 2011 | Hamilton Co Hamilton brand Disposable Syringe Pack for use with Microlab F.A.M.E; Part Number: 147692 (case containing 96 syringes); Manufactured by: Treff AG, Degersheim, Switzerland for Hamilton Bonaduz AG, Bo Terminated |
JJE | K943493 |
| Sep 9, 2009 | Hamilton Co 300 Microliter CO-RE Tips for use with Microlab STAR, manufactured by Hamilton Company, Reno, NV.
Product is a disposable product used with Microlab STAR series Instruments, which are microtiter dilu Terminated |
JTC | None listed |
| Apr 17, 2009 | Hamilton Co 300 microliter CO-RE tips for use with Microlab STAR series instruments, Part Number 235902, 5,760 tips per case, manufactured by Hamilton Company, Reno, NV.
The products are a disposable product tha Terminated |
JTC | None listed |
| Sep 17, 2008 | Hamilton Co Hamilton Soft Grip Pipettes, 1 ml adjustable volume, model number 55019-40
Product is indicated for manual pipetting. Terminated |
JQW | None listed |
| Sep 17, 2008 | Hamilton Co Hamilton Soft Grip Pipettes, 1 ml fixed volume, model number 55019-19
Product is indicated for manual pipetting. Terminated |
JQW | None listed |
| Feb 8, 2008 | Hamilton Co Hamilton Sample Carriers for the ML STAR line (SMP-CAR-24). Product Code: 866.2500; Part Number: 173400. Hamilton Company, Reno, NV 89520 (Accessory on the Microlab STAR series instruments.) Terminated |
JTC | None listed |
| Aug 16, 2007 | Hamilton Co Microlab F.A.M.E. reagent containers, Part number 148482, box containing 48 containers each. For in vitro diagnostic use. Terminated |
JQW | None listed |
| Apr 7, 2007 | Hamilton Co Hamilton brand Disposable Precision Tips,
Part Number 235300 (box containing 504 tips) and 235400 (case containing 20 boxes), Manufactured by Hamilton Company, Reno, Nevada Terminated |
-JT | None listed |
| Jun 22, 2006 | Hamilton Co 62 RNR Series 2.5 microliter syringe without needle,
Part#: 7632-01 Terminated |
JQW | None listed |
| Jun 22, 2006 | Hamilton Co Syringe, 62RNR 2.5 Microliter Syringe, with needle point style 3 (blunt needle point for use with HPLC injection valves and for sample pipetting) Part #: 87942. Terminated |
JQW | None listed |
| Feb 14, 2006 | Hamilton Co Microlab AT, part numbers 135001, 135001OOC, 135002, 135003, 135005, 135006, 135006R, 135007, 135008, 135016, 135028, 135029, 936400, 936400BLU.
Microlab AT+ and Microlab AT+2, part numbers 142000, Terminated |
JTC | K871945 |
| Oct 22, 2005 | Hamilton Co Y-valve and T-valve, PSD/4 Syringe Drive Module parts. Terminated |
JJC | None listed |