FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Eonis SCID-SMA Kit
K Number: DEN200044
·
Decision Nov 9, 2022
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
17
Review Days
854
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Basic Information
- Device Name
- Eonis SCID-SMA Kit
- K Number
- DEN200044
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 866.5980
- Medical Specialty
- Immunology
- Decision
- Unknown
- Applicant
- Perkinelmer, Inc.
- Date Received
- July 8, 2020
- Decision Date
- November 9, 2022
- Product Code
- QUE
- 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 |
|---|---|---|---|
| QUE | Spinal Muscular Atrophy Newborn Screening Test System | FDA class 2 | Immunology |
Other Clearances by Perkinelmer, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K203035 | Eonis SCID-SMA kit | Nov 9, 2022 | Substantially Equivalent |
| K193103 | NeoBase 2 Non-derivatized MSMS Kit | Feb 7, 2020 | Substantially Equivalent |
| DEN180056 | GSP Neonatal Creatine Kinase - MM kit | Dec 12, 2019 | Unknown |
| K190335 | GSP Neonatal Total Galactose kit | Nov 6, 2019 | Substantially Equivalent |
| K190266 | NeoLSD MSMS Kit | May 3, 2019 | Substantially Equivalent |
| K161966 | PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector | Sep 8, 2016 | Substantially Equivalent |
| K161942 | PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector | Sep 1, 2016 | Substantially Equivalent |
| K142698 | PerkinElmer, XRpad 4343 F MED Flat Panel Detector | Oct 23, 2014 | Substantially Equivalent |
| K140551 | PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR | Aug 1, 2014 | Substantially Equivalent |
| K121864 | PERKINELMER 226 SAMPLE COLLECTION DEVICES | Mar 12, 2013 | Substantially Equivalent |