FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022
K Number: K070853
·
Decision Jun 13, 2007
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
32
Applicant Total
343
Review Days
77
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Basic Information
- Device Name
- DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022
- K Number
- K070853
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3040
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dade Behring, Inc.
- Date Received
- March 28, 2007
- Decision Date
- June 13, 2007
- Product Code
- DIC
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| DIC | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | FDA class 2 | Clinical Toxicology |
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