510(k) K183176
- Device
- Endotoxin Activity Assay (EAA)
- Applicant
- Spectral Medical Inc.
- 510(k) number
- K183176
- Product code
- NGS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-03-12
- Date received
- 2018-11-16
- Regulation
- 866.3210
- Classification name
- Assay, Endotoxin Activity, Chemiluminescent
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Danijela Domljanovic
- Address
- 135 The W. Mall, Unit 2 Toronto CA M9C1C2 M9C1C2
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 |
|---|---|---|---|
| DEN030002 | ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE | Spectral Diagnostics, Inc. | 2003-06-16 |
FDA Review#
Decision Summary