FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Eonis SCID-SMA kit
K Number: K203035
·
Decision Nov 9, 2022
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
17
Review Days
765
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Basic Information
- Device Name
- Eonis SCID-SMA kit
- K Number
- K203035
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5930
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Perkinelmer, Inc.
- Date Received
- October 5, 2020
- Decision Date
- November 9, 2022
- Product Code
- PJI
- Advisory Committee
- Immunology
- Review Advisory Committee
- MG
- 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 |
|---|---|---|---|
| PJI | Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PJI), ordered by most recent decision date.
View allOther Clearances by Perkinelmer, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| DEN200044 | Eonis SCID-SMA Kit | Nov 9, 2022 | Unknown |
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| K121864 | PERKINELMER 226 SAMPLE COLLECTION DEVICES | Mar 12, 2013 | Substantially Equivalent |