Data / Medical devices / United States / Boston Cell Standards Inc
Boston Cell Standards Inc: FDA-registered device maker in Boston, MA, United States, 1 510(k) clearance
Boston Cell Standards Inc is registered with the FDA (registration 3023212278) in Boston, MA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 15, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023212278
- Address
- 800 Washington Street Ziskind 417, Boston, MA, United States, 02111
- Owner or operator
- Boston Cell Standards Inc (10086004)
- Roles
- Manufacturer
- First device listed
- October 9, 2022
- Registered through
- 2026
- Brand names listed
- HER2/ER/PR IHControls® - Level H, HER2/ER/PR IHControls® - Level L, HER2/ER/PR IHControls® - Level M
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Control Material, Her-2/Neu, Immunohistochemistry | NJW | 2 | 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 |
|---|---|---|---|---|---|---|
| August 15, 2022 | K220163 | Her-2, ER, PR IHControls | NJW | Substantially Equivalent | Boston Cell Standards, Inc. | accessdata.fda.gov |
Updated August 15, 2022. 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.