CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS
FDA 510(k) clearance K080459 · decided 2009-11-17
Clearance details
- K-number
- K080459
- Device name
- CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS
- Applicant
- Chromsystems Instruments & Chemicals GmbH
- Decision
- Substantially Equivalent
- Date received
- 2008-02-20
- Decision date
- 2009-11-17
- Days to decision
- 636 days
- Clearance type
- Abbreviated
- Product code
- LAS
- Device class
- 1
- Regulation number
- 862.3280
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Marietta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.