IMMULISA SCI-70 ANTIBODY ELISA
FDA 510(k) clearance K113143 · decided 2011-12-02
Clearance details
- K-number
- K113143
- Device name
- IMMULISA SCI-70 ANTIBODY ELISA
- Applicant
- Immco Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-10-25
- Decision date
- 2011-12-02
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- LLL
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Buffalo, NY, US
- Third-party review
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Immco Diagnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.