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

Assayed Quality Control Material For Clinical Microbiology Assays

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

QCH is the FDA product code for Assayed Quality Control Material For Clinical Microbiology Assays, a class II device type, regulated under 21 CFR 866.3920. FDA's definition for this code reads: "Serologic controls for microbiology assays". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QCH
Device name
Assayed Quality Control Material For Clinical Microbiology Assays
FDA definition
Serologic controls for microbiology assays
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
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QCH

By decision year
1 clearance under product code QCH with a decision year between 2025 and 2025, 2025 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QCH by decision year
YearClearances
20251

Applicants with the most clearances

Product code QCH
Applicants holding the most 510(k) clearances under product code QCH
ApplicantClearances
Techno-Path Manufacturing Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code