ENZYME LINEARITY CONTROL
FDA 510(k) clearance K912718 · decided 1991-09-06
Clearance details
- K-number
- K912718
- Device name
- ENZYME LINEARITY CONTROL
- Applicant
- Phoenix Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-06-18
- Decision date
- 1991-09-06
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- JJY
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Medfield, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Phoenix Diagnostics
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.