FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls
K Number: K163525
·
Decision Sep 5, 2017
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
26
Applicant Total
138
Review Days
264
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Basic Information
- Device Name
- QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls
- K Number
- K163525
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5090
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inova Diagnostics, Inc.
- Date Received
- December 15, 2016
- Decision Date
- September 5, 2017
- Product Code
- DBM
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | FDA class 2 | Immunology |
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