VALIDATE D-Dimer Calibration Verification/Linearity Test Kit
FDA 510(k) clearance K152961 · decided 2016-06-03
Clearance details
- K-number
- K152961
- Device name
- VALIDATE D-Dimer Calibration Verification/Linearity Test Kit
- Applicant
- Maine Standards Company, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-10-07
- Decision date
- 2016-06-03
- Days to decision
- 240 days
- Clearance type
- Traditional
- Product code
- GGN
- Device class
- 2
- Regulation number
- 864.5425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Cumberland Foreside, ME, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Maine Standards Company
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.