HAMILTON THORNE, Inc.
Beverly, MA, US
HAMILTON THORNE, Inc. appears in FDA device records in Beverly, MA. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no 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 4 510(k) clearances for HAMILTON THORNE, Inc. between 2012 and 2021. The busiest year on record is 2019, with 2. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2019 | 2 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K202241 | LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) | MRX | Substantially Equivalent | |
| K191552 | GM501 Mineral Oil | MQL | Substantially Equivalent | |
| K190383 | GM501 Wash | MQL | Substantially Equivalent | |
| K120055 | HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS | MRX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1221433 | 1221433 | HAMILTON THORNE, Inc. | 100 CUMMINGS CENTER-SUITE 465E, Beverly, MA 01915 US | 2026 | and 8 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MQGAccessory, Assisted Reproduction
- PUBAccessory, Assisted Reproduction, Exempt
- MQFCatheter, Assisted Reproduction
- GKLCounter, Cell, Automated (Particle Counter)
- GKZCounter, Differential Cell
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- MQKLabware, Assisted Reproduction
- PUDLabware, Assisted Reproduction, Exempt
- NRFMaterial, Quality Control, Semen Analysis
- MQLMedia, Reproductive
- QKIMedia, Reproductive, Exempt
- MQJMicromanipulators And Microinjectors, Assisted Reproduction
- MTXMicroscope And Microscope Accessories, Reproduction, Assisted
- PUCMicrotools, Assisted Reproduction (Pipettes), Exempt
- OTQResearch Use Only/Hematology Devices
- POVSemen Analysis Device
- MRXSystem, Assisted Reproduction Laser
- IAFWright'S Stain
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain