510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PMNClass II

Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

21 CFR 866.3920 / Microbiology
FDA source (opens on fda.gov)

PMN is the FDA product code for Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays, a class II device type, regulated under 21 CFR 866.3920. FDA's definition for this code reads: "Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use". As of , FDA records hold 32 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
PMN
Device name
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
FDA definition
Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.
Regulation
21 CFR 866.3920
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
32
Ingested recalls
4

Clearances, product code PMN

By decision year
32 clearances under product code PMN with a decision year between 2016 and 2026, 2019 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code PMN by decision year
YearClearances
20163
20172
20183
20196
20202
20211
20223
20234
20242
20251
20265

Applicants with the most clearances

Product code PMN
Applicants holding the most 510(k) clearances under product code PMN
ApplicantClearances
Maine Molecular Quality Controls, Inc.13
Microbiologics, Inc.8
Streck LLC6
Bio-Rad Laboratories Inc.2
BioFire Defense, LLC2
Zeptometrix LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code