EBNA IGG EIA TEST SYSTEM
FDA 510(k) clearance K951549 · decided 1996-04-29
Clearance details
- K-number
- K951549
- Device name
- EBNA IGG EIA TEST SYSTEM
- Applicant
- Immunoprobe, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-04-04
- Decision date
- 1996-04-29
- Days to decision
- 391 days
- Clearance type
- Traditional
- Product code
- LLM
- Device class
- 1
- Regulation number
- 866.3235
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Washington, D.C., DC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Immunoprobe
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.