FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516
K Number: K062191
·
Decision Aug 21, 2006
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
201
Applicant Total
343
Review Days
21
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Basic Information
- Device Name
- DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516
- K Number
- K062191
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3280
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dade Behring, Inc.
- Date Received
- July 31, 2006
- Decision Date
- August 21, 2006
- Product Code
- DIF
- 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 |
|---|---|---|---|
| DIF | Drug Mixture Control Materials | FDA class 1 | Clinical Toxicology |
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FDA 510(k)
FDA Class 1
·Clinical Toxicology
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| K073055 | DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 | Jan 3, 2008 | Substantially Equivalent |
| K072965 | DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON | Dec 21, 2007 | Substantially Equivalent |