GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION
FDA 510(k) clearance K132272 · decided 2013-10-17
Clearance details
- K-number
- K132272
- Device name
- GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION
- Applicant
- Glooko, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-07-22
- Decision date
- 2013-10-17
- Days to decision
- 87 days
- Clearance type
- Special
- Product code
- NBW
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.