FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DOUMENT TM LINEARITY TEST STANDARDS
K Number: K843947
·
Decision Oct 17, 1984
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
301
Applicant Total
38
Review Days
8
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Basic Information
- Device Name
- DOUMENT TM LINEARITY TEST STANDARDS
- K Number
- K843947
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Casco Standards
- Date Received
- October 9, 1984
- Decision Date
- October 17, 1984
- Product Code
- JIX
- 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 |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | FDA class 2 | Clinical Chemistry |
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