Endotoxin Activity Assay (EAA)
FDA 510(k) clearance K183176 · decided 2019-03-12
Clearance details
- K-number
- K183176
- Device name
- Endotoxin Activity Assay (EAA)
- Applicant
- Spectral Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-11-16
- Decision date
- 2019-03-12
- Days to decision
- 116 days
- Clearance type
- Special
- Product code
- NGS
- Device class
- 2
- Regulation number
- 866.3210
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Toronto, CA
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE (DEN030002) | Spectral Diagnostics, Inc. | 2003-06-16 |
Recalls involving this device
No recalls on record reference this clearance.