FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set
K Number: K161646
·
Decision Nov 4, 2016
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
63
Applicant Total
41
Review Days
142
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Basic Information
- Device Name
- Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set
- K Number
- K161646
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1295
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Diazyme Laboratories
- Date Received
- June 15, 2016
- Decision Date
- November 4, 2016
- Product Code
- CGN
- 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 |
|---|---|---|---|
| CGN | Acid, Folic, Radioimmunoassay | FDA class 2 | Clinical Chemistry |
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