510(k) K030370
- Device
- REDLINE ANTHRAX ALERT TEST
- Applicant
- TETRACORE, INC
- 510(k) number
- K030370
- Product code
- NPO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-12-09
- Date received
- 2003-02-04
- Regulation
- 866.3045
- Classification name
- Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- BEVERLY L MANGOLD
- Address
- 11 Firstfield Rd. Suite C Gaithersburg, MD US 20878 20878
FDA Registration Numbers
- 3003517954
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G143TC51230101 | RedLine Alert™ Test Kit | Tetracore, Inc. | 2022-06-15 |
Legacy Summary
summary
FDA Review
Decision Summary