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

Enzyme Immunoassay, Fetal Fibronectin

Unknown
FDA source (opens on fda.gov)

LKV is the FDA product code for Enzyme Immunoassay, Fetal Fibronectin, a class III device type. As of , FDA records hold no 510(k) clearances under this code and 7 recalls.

Classification record

Product code
LKV
Device name
Enzyme Immunoassay, Fetal Fibronectin
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
7

Companies listing this code with FDA

Companies whose registered establishments list this code