Data / Medical devices / United States / AirScan, Inc.
AirScan, Inc.: FDA-registered device maker in Annandale, NJ, United States, 2 510(k) clearances
AirScan, Inc. is registered with the FDA (registration 2249801) in Annandale, NJ, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 17, 1999. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2249801
- FEI number
- 3003238169
- Address
- 67 Beaver Ave, Annandale, NJ, United States, 08801
- Owner or operator
- AirScan, Inc (9042127)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- July 31, 2001
- Registered through
- 2026
- Brand names listed
- E-Z Safe Analysis Tubes, ESR STAT 6, HemaTechnologies ESR Control
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Automated Sedimentation Rate | GKB | 1 | Manufacturer | accessdata.fda.gov |
| Mixture, Hematology Quality Control | JPK | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tube, Collection, Capillary Blood | GIO | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| June 17, 1999 | K991876 | SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| December 1, 1988 | K884623 | SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE | GIO | Substantially Equivalent | Safe-Tec Clinical Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Tube, Collection, Capillary Blood
- All makers of Mixture, Hematology Quality Control
- All makers of Device, Automated Sedimentation Rate
Updated June 17, 1999. 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.