FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)
K Number: DEN230092
·
Decision Jul 15, 2024
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
11
Review Days
200
Basic Information
- Device Name
- Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)
- K Number
- DEN230092
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 866.3967
- Medical Specialty
- Microbiology
- Decision
- Unknown
- Applicant
- DiaSorin Molecular LLC
- Date Received
- December 28, 2023
- Decision Date
- July 15, 2024
- Product Code
- SBT
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| SBT | Device To Detect Microbial Colonization Directly From Clinical Specimens. | FDA class 2 | Microbiology |
Other Clearances by DiaSorin Molecular LLC
| K Number | Device Name | ||
|---|---|---|---|
| K220963 | Simplexa COVID-19 & Flu A/B Direct | Mar 17, 2023 | Substantially Equivalent |
| K202755 | Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack | Nov 5, 2022 | Substantially Equivalent |
| K212147 | Simplexa COVID-19 Direct | Sep 13, 2022 | Substantially Equivalent |
| K201505 | Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack | Aug 22, 2020 | Substantially Equivalent |
| K192376 | Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack | Nov 26, 2019 | Substantially Equivalent |
| K190219 | Simplexa VZV Direct, Simplexa VZV Positive Control Pack | May 13, 2019 | Substantially Equivalent |
| K183223 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | Dec 19, 2018 | Substantially Equivalent |
| K182467 | Simplexa GBS Direct, Simplexa GBS Positive Control Pack | Nov 7, 2018 | Substantially Equivalent |
| K173498 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | Aug 13, 2018 | Substantially Equivalent |
| K173798 | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack | Mar 14, 2018 | Substantially Equivalent |