IMMUNOWELL EBNA IGG TEST
FDA 510(k) clearance K973941 · decided 1998-08-10
Clearance details
- K-number
- K973941
- Device name
- IMMUNOWELL EBNA IGG TEST
- Applicant
- Genbio
- Decision
- Substantially Equivalent
- Date received
- 1997-10-15
- Decision date
- 1998-08-10
- Days to decision
- 299 days
- Clearance type
- Traditional
- Product code
- LLM
- Device class
- 1
- Regulation number
- 866.3235
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Genbio
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.