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

Hyaline Membrane Disease Assay

Unknown
FDA source (opens on fda.gov)

LTC is the FDA product code for Hyaline Membrane Disease Assay, a class III device type. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
LTC
Device name
Hyaline Membrane Disease Assay
Device class
Class III
Review panel
Unknown
Submission type
Contact ODE
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code LTC

By decision year
1 clearance under product code LTC with a decision year between 1985 and 1985, 1985 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LTC by decision year
YearClearances
19851

Applicants with the most clearances

Product code LTC
Applicants holding the most 510(k) clearances under product code LTC
ApplicantClearances
Dow Corning Corp. Healthcare Industries Materials1

Companies listing this code with FDA

Companies whose registered establishments list this code

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