FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PATHFAST CTNL CALIBRATORS
K Number: K130603
·
Decision Mar 27, 2014
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
244
Applicant Total
2
Review Days
385
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Basic Information
- Device Name
- PATHFAST CTNL CALIBRATORS
- K Number
- K130603
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mitsubishi Chemical Medience Corporation
- Date Received
- March 7, 2013
- Decision Date
- March 27, 2014
- 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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Other Clearances by Mitsubishi Chemical Medience Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K130628 | PATHFAST CK-MB-II CALIBRATORS | Oct 4, 2013 | Substantially Equivalent |