QUANTA LITE OMP PLUS ELISA
FDA 510(k) clearance K081248 · decided 2008-10-27
Clearance details
- K-number
- K081248
- Device name
- QUANTA LITE OMP PLUS ELISA
- Applicant
- Inova Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-05-02
- Decision date
- 2008-10-27
- Days to decision
- 178 days
- Clearance type
- Traditional
- Product code
- OKM
- Device class
- 2
- Regulation number
- 866.5785
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Inova 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.
Recalls involving this device
No recalls on record reference this clearance.