BOSTON CELL STANDARDS INC

FDA Device Registration & Listing · Boston, MA, US · Registration 3023212278

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3023212278
FEI Number
3023212278
Entity Name
BOSTON CELL STANDARDS INC
City/State/Country
Boston, MA, US
Establishment Address
800 Washington Street, Ziskind 417, Boston, MA 02111, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Boston Cell Standards Inc (Owner Number: 10086004)
Owner / Operator Contact Address
800 Washington Street, Ziskind 417, Boston, MA 02111, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K220163
PMA Number
N/A

All Registered Proprietary Names

HER2/ER/PR IHControls® - Level L HER2/ER/PR IHControls® - Level H HER2/ER/PR IHControls® - Level M

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NJW Control Material, Her-2/Neu, Immunohistochemistry Hematology Class 2 864.1860 2022-10-09

Official Correspondent

Steve Bogen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Boston Cell Standards Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023212278. Last updated year: 2026. Please use registration number 3023212278 when referencing this establishment in official correspondence.
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