510(k) K231221
K231221 is an FDA 510(k) premarket notification submitted by Streck for the device "MDx-Chex for BC-GP". The FDA issued a decision of Substantially Equivalent on July 27, 2023. The device falls under product code PMN (Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays), a Class II device regulated under 21 CFR 866.3920. Streck has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 2023
- Date Received
- April 28, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
- Device Class
- Class II
- Regulation Number
- 866.3920
- Review Panel
- MI
- Submission Type
Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.