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

Multiple Use Blood Lancet For Multiple Patient Use

21 CFR 878.4850 / General, Plastic Surgery
FDA source (opens on fda.gov)

QRM is the FDA product code for Multiple Use Blood Lancet For Multiple Patient Use, a class III device type, regulated under 21 CFR 878.4850. FDA's definition for this code reads: "A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QRM
Device name
Multiple Use Blood Lancet For Multiple Patient Use
FDA definition
A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.
Regulation
21 CFR 878.4850
Device class
Class III
Review panel
General, Plastic Surgery
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code QRM.