ORGENTEC RHEUMATOID FACTOR EIA
FDA 510(k) clearance K100499 · decided 2010-10-27
Clearance details
- K-number
- K100499
- Device name
- ORGENTEC RHEUMATOID FACTOR EIA
- Applicant
- Orgentec Diagnostika GmbH
- Decision
- Substantially Equivalent
- Date received
- 2010-02-22
- Decision date
- 2010-10-27
- Days to decision
- 247 days
- Clearance type
- Traditional
- Product code
- DHR
- Device class
- 2
- Regulation number
- 866.5775
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- East Stroudsburg, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Orgentec Diagnostika GmbH
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.