FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MDx-Chex for BCID2
K Number: K212576
·
Decision Jan 19, 2022
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
30
Applicant Total
3
Review Days
156
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Basic Information
- Device Name
- MDx-Chex for BCID2
- K Number
- K212576
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3920
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Streck, Inc.
- Date Received
- August 16, 2021
- Decision Date
- January 19, 2022
- 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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