K181683 is an FDA 510(k) clearance for the BD MAX CT/GC/TV 20-Day QC Panel. This device is classified as a Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays (Class II - Special Controls, product code PMN).
Submitted by Microbiologics, Inc. (St. Cloud, US). The FDA issued a Cleared decision on August 28, 2018, 63 days after receiving the submission on June 26, 2018.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3920. Assayed External Quality Control Material To Monitor The Performance Of Microbiology Nucleic Acid Assays For In Vitro Diagnostic Use..
| 510(k) Number | K181683 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2018 |
| Decision Date | August 28, 2018 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | PMN — Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3920 |
| Definition | Assayed External Quality Control Material To Monitor The Performance Of Microbiology Nucleic Acid Assays For In Vitro Diagnostic Use. |