BRONCHIAL CYTOLOGY BRUSH
FDA 510(k) clearance K853667 · decided 1985-12-18
Clearance details
- K-number
- K853667
- Device name
- BRONCHIAL CYTOLOGY BRUSH
- Applicant
- E-Z-Em, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-09-03
- Decision date
- 1985-12-18
- Days to decision
- 106 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Westbury, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch E-Z-Em
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.