Data / Medical devices / United States / Thermo Fisher Scientific (asheville) LLC
Thermo Fisher Scientific (asheville) LLC: FDA-registered device maker in Marietta, OH, United States, 3 510(k) clearances
Thermo Fisher Scientific (asheville) LLC is registered with the FDA (registration 1523845) in Marietta, OH, United States. It lists 7 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 15, 2002. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 1523845
- Address
- 401 Millcreek RD., Marietta, OH, United States, 45750
- Owner or operator
- THERMO FISHER SCIENTIFIC INC. (2182773)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- September 11, 1978
- Registered through
- 2026
- Brand names listed
- ALIQUOTER AND LABELLER, BUFFER, BULK INTERFACE MODULE, CENTRIFUGE FLEX MODULE, CENTRIFUGE MODULE, CONVEYOR 1200 MM, CONVEYOR 1500 MM, CONVEYOR 1800 MM and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Assisted Reproduction | MQG | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Anaerobic Box Glove | JTM | 1 | Manufacturer | accessdata.fda.gov |
| Bath, Incubators/Water, All | JTQ | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 | Contract manufacturer | accessdata.fda.gov |
| Freezer | JRM | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Refrigerator, Freezer, Blood Storage | KSE | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Shaker/Stirrer | JRQ | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 15, 2002 | K021042 | THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS; MODELS # 7456, 7457, 7458,7459,7475,7476 | MQG | Substantially Equivalent | Thermo Forma, Inc. | accessdata.fda.gov |
| July 12, 2000 | K001524 | FORMA SCIENTIFIC DIRECT HEAT INCUBATORS | MQG | Substantially Equivalent | Thermoquest Corp. | accessdata.fda.gov |
| July 19, 1999 | K991408 | FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR | MQG | Substantially Equivalent | Thermoquest Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 2, 2019 | 82903 | Class II | Terminated | Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 5L GP Bath Model Number: FSGPD05 | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user. | accessdata.fda.gov |
| November 29, 2012 | 64418 | Class II | Terminated | CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3598, and 3599. Product Usage: Incubators are designed to maintain an optimal envi | Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessory, Assisted Reproduction
- All makers of Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- All makers of Refrigerator, Freezer, Blood Storage
- All makers of Shaker/Stirrer
- All makers of Freezer
- All makers of Anaerobic Box Glove
Updated May 15, 2002. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.