Hamilton Co
Reno, NV, US
HAMILTON CO. appears in FDA device records in Reno, NV. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 13 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 16 510(k) clearances for Hamilton Co between 1980 and 1996. The busiest year on record is 1983, with 9. The most recent is 1996, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1982 | 1 |
| 1983 | 9 |
| 1987 | 1 |
| 1988 | 1 |
| 1989 | 1 |
| 1995 | 1 |
| 1996 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K961896 | MICROLAB 4000, MICROLAB 4200 | JQW | Substantially Equivalent | |
| K943493 | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER | JJE | Substantially Equivalent | |
| K892369 | MULTI-PROBE HEAD PLUS | JTC | Substantially Equivalent | |
| K873893 | LUMICON | JJQ | Substantially Equivalent | |
| K871945 | MICROLAB AT | JTC | Substantially Equivalent | |
| K832205 | PRECISION LIQUID DISPENSER | JQW | Substantially Equivalent | |
| K832204 | MICROLAB P | JQW | Substantially Equivalent | |
| K832202 | PB 600 REPEATING DISPENSER | JQW | Substantially Equivalent | |
| K832201 | CHROM-PREP | KZR | Substantially Equivalent | |
| K832200 | PRP-1 REVERSED PHASE COLUMNS FOR HPLC | DPM | Substantially Equivalent | |
| K832199 | HC40/HC75 CATION EXCHANGE RESIN | DNH | Substantially Equivalent | |
| K832198 | HC40/HC75 PREPACKED COLUMS | DJY | Substantially Equivalent | |
| K832197 | PRP-1 REVERSED PHASE RESIN | DMZ | Substantially Equivalent | |
| K832203 | MULTI-TITER DISPENSER | JTC | Substantially Equivalent | |
| K822688 | DIGITAL DILUTER/DISPENSERS | JQW | Substantially Equivalent | |
| K801913 | MICROLAB M-MICROPROCESSOR DILUTER/DISP | JQW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2915796 | 2915796 | HAMILTON CO. | 4970 ENERGY WAY, Reno, NV 89502 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- KZRChromatography (Liquid, Gel), Clinical Use
- JJHClinical Sample Concentrator
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- DPMColumns, Liquid Chromatography
- JTCDevice, Microtiter Diluting/Dispensing
- DJYIon-Exchange Chromatography
- DMZLiquid Chromatography, Adsorbent
- DNHResins, Ion-Exchange, Liquid Chromatography
- JQWStation, Pipetting And Diluting, For Clinical Use
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1156-2021 | HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% - 85% no condensation. REF 19903400 | There is a risk that the device can start a fire if flammable liquids contact and enter the device. | Class II | Open, Classified | |
| Z-0103-2012 | 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, Bonaduz, Switzerland (Manufacturer of record); Product is distributed by Hamilton Company, Reno, NV The F.A.M.E Syringes are a disposable product that is used on our Microlab F.A.M.E. series instruments for diluting/dispensing. Microlab F.A.M.E was released under 510(k) K943493/S1 under product codes JJE (862.2160 Discrete Photometric Chemistry Analyzer for Clinical Use), JJQ (862.2300 Colorimeter, photometer, or spectrophotometer for Clinical Use), and JTC (866.2500 Microtiter Diluting/Dispensing Device), all of which are currently Class I exempt devices. The syringes are also used on Ortho Summit Processor instruments distributed by Ortho-Clinical Diagnostics. | Certain lots of syringes have caused an increase in error message "DIS541", which indicates "improper dispensation". | Terminated | ||
| Z-1999-2009 | 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 diluting and dispensing devices. | Product Defect-- some tips from the mold cavity 28 are too short and do not always aspirate or dispense liquid correctly. | Terminated | ||
| Z-1203-2009 | 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 that are used with the Microlab STAR series instruments, which are microtiter diluting and dispensing devices. | Some tips may be occluded and are unable to aspirate or dispense liquid. | Terminated | ||
| Z-2233-2008 | Hamilton Soft Grip Pipettes, 1 ml adjustable volume, model number 55019-40 Product is indicated for manual pipetting. | Manufacturing issue with spring may restrict product to drawing less than 1/2 of its stated measured capacity | Terminated | ||
| Z-2232-2008 | Hamilton Soft Grip Pipettes, 1 ml fixed volume, model number 55019-19 Product is indicated for manual pipetting. | Manufacturing issue with spring may restrict product to drawing less than 1/2 of its stated measured capacity | Terminated | ||
| Z-0718-2008 | 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.) | Incorrectly labeled-- Product has the wrong barcode labeling. The barcode error will not influence the results of testing. The instrument will discover the error and post an error notice. | Terminated | ||
| Z-1169-2007 | Microlab F.A.M.E. reagent containers, Part number 148482, box containing 48 containers each. For in vitro diagnostic use. | Some product containers may be leaking. | Terminated | ||
| Z-0723-2007 | Hamilton brand Disposable Precision Tips, Part Number 235300 (box containing 504 tips) and 235400 (case containing 20 boxes), Manufactured by Hamilton Company, Reno, Nevada | Some of the packaged tips have increased force during aspiration, which can lead to pipetting errors such as LLD error messages, and also has risk of causing a missed pipetting. | Terminated | ||
| Z-1170-06 | 62 RNR Series 2.5 microliter syringe without needle, Part#: 7632-01 | There is an error in the marking of the graduated divisions on syringes in affected lots that shows an amount that is double the actual volume of the syringe | Terminated | ||
| Z-1169-06 | 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. | There is an error in the marking of the graduated divisions on syringes in affected lots that shows an amount that is double the actual volume of the syringe | Terminated | ||
| Z-0514-06 | 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, 142001, 142001R, 142002, 142003, 142005, 142006, 142006R, 142007, 142008, 142009, 142015, 142017, 142035, 142036 | Heat sinking on power boards may not operate as intended and the board may cease to operate. | Terminated | ||
| Z-0087-06 | Y-valve and T-valve, PSD/4 Syringe Drive Module parts. | The product valve has a high probability of deforming and may result in leakage during use. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain