510(k) DEN030002
- Device
- ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE
- Applicant
- Spectral Diagnostics, Inc.
- 510(k) number
- DEN030002
- Product code
- NGS
- Decision
- Unknown (DENG)
- Decision date
- 2003-06-16
- Date received
- 2003-04-14
- Regulation
- 866.3210
- Classification name
- Assay, Endotoxin Activity, Chemiluminescent
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- TOM TSAKERIS
- Address
- 16809 Briardale Rd. Rockville MD US 20855 20855
FDA Registration Numbers#
- 9617857
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NGS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K183176 | Endotoxin Activity Assay (EAA) | Spectral Medical, Inc. | 2019-03-12 |