FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MDx-Chex for BCN
K Number: K254166
·
Decision Mar 23, 2026
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
30
Applicant Total
33
Review Days
90
Basic Information
- Device Name
- MDx-Chex for BCN
- K Number
- K254166
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3920
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Streck
- Date Received
- December 23, 2025
- Decision Date
- March 23, 2026
- Product Code
- PMN
- 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 |
|---|---|---|---|
| PMN | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays | FDA class 2 | Microbiology |
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Other Clearances by Streck
| K Number | Device Name | ||
|---|---|---|---|
| K231223 | MDx-Chex for BC-GN | Jul 27, 2023 | Substantially Equivalent |
| K231221 | MDx-Chex for BC-GP | Jul 27, 2023 | Substantially Equivalent |
| K170091 | UA-Cellular Complete | Feb 9, 2017 | Substantially Equivalent |
| K160588 | XN CHECK BF | Dec 22, 2016 | Substantially Equivalent |
| K160586 | XN-L CHECK | Dec 22, 2016 | Substantially Equivalent |
| K160585 | XN CAL | Dec 22, 2016 | Substantially Equivalent |
| K160590 | XN CHECK | Dec 22, 2016 | Substantially Equivalent |
| K141957 | XN CHECK BF | Dec 5, 2014 | Substantially Equivalent |
| K141964 | XN CHECK | Dec 5, 2014 | Substantially Equivalent |
| K141962 | XN CAL | Dec 5, 2014 | Substantially Equivalent |