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

System, Test, Urinary Methylmalonic Acid

21 CFR 862.1509 / Clinical Chemistry
FDA source (opens on fda.gov)

LPT is the FDA product code for System, Test, Urinary Methylmalonic Acid, a class II device type, regulated under 21 CFR 862.1509. As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
LPT
Device name
System, Test, Urinary Methylmalonic Acid
Regulation
21 CFR 862.1509
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code