FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECSYS LH CALSET II
K Number: K031299
·
Decision May 12, 2003
Classifications
1
FEI Numbers
134
Registration Numbers
134
Same Product Code
244
Applicant Total
264
Review Days
18
Basic Information
- Device Name
- ELECSYS LH CALSET II
- K Number
- K031299
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ROCHE DIAGNOSTICS CORP.
- Date Received
- April 24, 2003
- Decision Date
- May 12, 2003
- Product Code
- JIT
- 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 |
|---|---|---|---|
| JIT | Calibrator, Secondary | FDA class 2 | Clinical Chemistry |
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