FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II
K Number: K043320
·
Decision Dec 17, 2004
Classifications
1
FEI Numbers
280
Registration Numbers
280
Same Product Code
492
Applicant Total
264
Review Days
15
Basic Information
- Device Name
- MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II
- K Number
- K043320
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ROCHE DIAGNOSTICS CORP.
- Date Received
- December 2, 2004
- Decision Date
- December 17, 2004
- Product Code
- JJX
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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