FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
GSP Neonatal Creatine Kinase - MM kit
K Number: DEN180056
·
Decision Dec 12, 2019
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
17
Review Days
427
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Basic Information
- Device Name
- GSP Neonatal Creatine Kinase - MM kit
- K Number
- DEN180056
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 862.1506
- Medical Specialty
- Clinical Chemistry
- Decision
- Unknown
- Applicant
- Perkinelmer, Inc.
- Date Received
- October 11, 2018
- Decision Date
- December 12, 2019
- Product Code
- QJE
- 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 |
|---|---|---|---|
| QJE | Muscular Dystrophy Newborn Screening Test | FDA class 2 | Clinical Chemistry |
Other Clearances by Perkinelmer, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| DEN200044 | Eonis SCID-SMA Kit | Nov 9, 2022 | Unknown |
| K203035 | Eonis SCID-SMA kit | Nov 9, 2022 | Substantially Equivalent |
| K193103 | NeoBase 2 Non-derivatized MSMS Kit | Feb 7, 2020 | Substantially Equivalent |
| 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 |