510(k) clearances

eplex RP3 Control M530; eplex RP3 Negative

Maine Molecular Quality Controls, Inc. · Microbiology

K263232Substantially EquivalentTraditionalPMN
Open FDA's page for this record
Third party flag
N
City
Saco
Advisory committee description
Microbiology
Address 1
23 Mill Brook Rd.
Statement or summary
Summary
Product code
PMN
Zip code
04072
Applicant
Maine Molecular Quality Controls, Inc.
Decision date
2026-10-30
Decision code
SESE
Country code
US
Device name
eplex RP3 Control M530; eplex RP3 Negative
Advisory committee
MI
Contact
Joan Gordon
K number
K263232
State
ME
Date received
2026-09-16
Review advisory committee
MI
Postal code
04072
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Medical specialty description
Microbiology
Regulation number
866.3920
Device class
2
Registration number
3010127294, 1528450, 2150138, 2024800, 3010770794, 3005959679, 2023365, 3023999024, 2024674, 2016706, 1950302
FEI number
3010127294, 2150138, 1000122536, 2024800, 3010770794, 3005959679, 2023365, 3023999024, 2024674, 2016706, 1950302
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.