FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICT TSH
K Number: K110761
·
Decision Mar 9, 2012
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
241
Applicant Total
1
Review Days
357
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Basic Information
- Device Name
- MICT TSH
- K Number
- K110761
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1690
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Magnabiosciences, LLC
- Date Received
- March 18, 2011
- Decision Date
- March 9, 2012
- Product Code
- JLW
- 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 |
|---|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | FDA class 2 | Clinical Chemistry |
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