FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHOLINESTERASE GEN.2 TEST SYSTEM
K Number: K061093
·
Decision Jul 3, 2006
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
25
Applicant Total
264
Review Days
75
Basic Information
- Device Name
- CHOLINESTERASE GEN.2 TEST SYSTEM
- K Number
- K061093
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3240
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ROCHE DIAGNOSTICS CORP.
- Date Received
- April 19, 2006
- Decision Date
- July 3, 2006
- Product Code
- DIH
- 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 |
|---|---|---|---|
| DIH | Colorimetry, Cholinesterase | FDA class 1 | Clinical Toxicology |
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