Data / Medical devices / United States / Fisher Scientific Company L.L.C.
Fisher Scientific Company L.L.C.: FDA-registered device maker in Pittsburgh, PA, United States, 1 510(k) clearance
Fisher Scientific Company L.L.C. is registered with the FDA (registration 2517925) in Pittsburgh, PA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 8, 2013. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2517925
- Address
- 300 Industry Dr Regulatory Affairs, Pittsburgh, PA, United States, 15275
- Owner or operator
- Thermo Fisher Scientific (2517925)
- Roles
- Complaint file establishment
- First device listed
- May 22, 2020
- Registered through
- 2026
- Brand names listed
- InterGlove Vinyl Gloves
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Vinyl Patient Examination Glove | LYZ | 1 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| November 8, 2013 | K130101 | BYTECH | LYZ | Substantially Equivalent | Bytech Dongtai Co., Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 5, 2014 | 67786 | Class II | Terminated | Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab,.025 and.035 in Diameter, all lots, 100 per pack Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Plastic Applicator Swab, all lot | A customer reported the presence of an organism in a lot of Calcium Alginate Fiber Tipped Wood Applicator Swab. | accessdata.fda.gov |
| June 5, 2013 | 65822 | Class II | Terminated | Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100 pouches/boxes, 10 boxes/case. Used in applying medications to or take specimens from a patient. | The firm is recalling Fisherbrand Sterile Swabs due to 4 customer complaints reporting the presence of non-pathogenic organisms in two lots. The finding was confirmed in lot 61513 and lot 8710 is also being recalled as a precautionary measure. | accessdata.fda.gov |
Compare with other makers
Updated April 28, 2014. 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.