FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS
K Number: K080459
·
Decision Nov 17, 2009
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
82
Applicant Total
1
Review Days
636
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Basic Information
- Device Name
- CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS
- K Number
- K080459
- Device Class
- FDA class 1
- Clearance Type
- Abbreviated
- Regulation Number
- 862.3280
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Chromsystems Instruments & Chemicals GmbH
- Date Received
- February 20, 2008
- Decision Date
- November 17, 2009
- Product Code
- LAS
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LAS | Drug Specific Control Materials | FDA class 1 | Clinical Toxicology |
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