510(k) clearance
eplex RP3 Control M530; eplex RP3 Negative
- 510(k) number
- K263232
- Applicant
- Maine Molecular Quality Controls, Inc.
- Decision date
- Oct 30, 2026
- Date received
- Sep 16, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- PMN
- Device type
- Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
- Device class
- Class II
- Regulation
- 21 CFR 866.3920
- Advisory committee
- Microbiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Saco, ME, US