K241289
- 510(k) number
- K241289
- Device name
- SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control
- Applicant
- Maine Molecular Quality Controls, Inc. ME · US
- Product code
- PMN — Assayed External Control Material For Microbiology N
- Decision date
- 2024-05-30
- Date received
- 2024-05-07
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K241289.pdf
Official FDA record: K241289
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.