EVATEST STRIP
FDA 510(k) clearance K936013 · decided 1994-02-25
Clearance details
- K-number
- K936013
- Device name
- EVATEST STRIP
- Applicant
- Boehringer Mannheim Italia Spa
- Decision
- Substantially Equivalent
- Date received
- 1993-12-16
- Decision date
- 1994-02-25
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- LCX
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- I-20126 Milano, Italy, IT
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Boehringer Mannheim Italia Spa
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.