ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087
FDA 510(k) clearance K091460 · decided 2009-08-06
Clearance details
- K-number
- K091460
- Device name
- ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087
- Applicant
- American Biological Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-05-18
- Decision date
- 2009-08-06
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- JJX
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Seguin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.