K233611
- 510(k) number
- K233611
- Device name
- SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)
- Applicant
- Maine Molecular Quality Controls, Inc. ME · US
- Product code
- PMN — Assayed External Control Material For Microbiology N
- Decision date
- 2024-03-26
- Date received
- 2023-11-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K233611.pdf
Official FDA record: K233611
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.