FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Diazyme 1,5-AG Assay
K Number: K180209
·
Decision Oct 4, 2018
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
1
Applicant Total
11
Review Days
253
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Basic Information
- Device Name
- Diazyme 1,5-AG Assay
- K Number
- K180209
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7470
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diazyme Laboratories, Inc.
- Date Received
- January 24, 2018
- Decision Date
- October 4, 2018
- Product Code
- NOZ
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| NOZ | Assay, 1,5-Anhydroglucitol (15ag) | FDA class 2 | Hematology |
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