510(k) clearances

SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control

Maine Molecular Quality Controls, Inc. · Microbiology

K262573Substantially 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
2026-10-21
Decision code
SESE
Country code
US
Device name
SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control
Advisory committee
MI
Contact
Joan Gordon
K number
K262573
State
ME
Date received
2026-07-27
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
2150138, 3023999024, 2023365, 3010127294, 1528450, 2024800, 2016706, 1950302, 2024674, 3010770794, 3005959679
FEI number
2150138, 3023999024, 2023365, 3010127294, 2024800, 2016706, 1950302, 2024674, 3010770794, 3005959679, 1000122536
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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.