AirScan, Inc.

FDA Device Registration & Listing · Annandale, NJ, US · Registration 2249801

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
2249801
FEI Number
3003238169
Entity Name
AirScan, Inc.
City/State/Country
Annandale, NJ, US
Establishment Address
67 Beaver Ave, Annandale, NJ 08801, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
AirScan, Inc (Owner Number: 9042127)
Owner / Operator Contact Address
65 Beaver Avenue STE 14, --, Annandale, NJ 08801, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

E-Z Safe Analysis Tubes HemaTechnologies ESR Control ESR STAT 6

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GIO Tube, Collection, Capillary Blood Hematology Class 1 864.6150 2016-02-15
JPK Mixture, Hematology Quality Control Hematology Class 2 864.8625 2016-05-04
GKB Device, Automated Sedimentation Rate Hematology Class 1 864.5800 2001-07-31

Official Correspondent

STEPHEN SHOEMAKER

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AirScan, Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K781077 Dade, Baxter Travenol Diagnostics, Inc. CONTROL, HEMATOLOGY, CH-60 1978-07-27

Similar Registrations

Registration Number Establishment Name Location
3015908492 VETIRUS, LLC Naples, FL, US
1000555938 SC-SANGUIS COUNTING GMBH NUEMBRECHT North Rhine-Westphalia, DE
9610126 ROCHE DIAGNOSTICS GMBH MANNHEIM Baden-Wurttemberg, DE
3005739529 Zhejiang Gongdong Medical Technology Co., Ltd TAIZHOU Zhejiang, CN
1064584 DEMETECH CORP. Miami Lakes, FL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2249801. Last updated year: 2026. Please use registration number 2249801 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.