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

Discs, Elution

21 CFR 866.1620 / Microbiology
FDA source (opens on fda.gov)

LTX is the FDA product code for Discs, Elution, a class II device type, regulated under 21 CFR 866.1620. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LTX
Device name
Discs, Elution
Regulation
21 CFR 866.1620
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
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code LTX

By decision year
2 clearances under product code LTX with a decision year between 1999 and 2000, 1999 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LTX by decision year
YearClearances
19991
20001

Applicants with the most clearances

Product code LTX
Applicants holding the most 510(k) clearances under product code LTX
ApplicantClearances
Ab Biodisk2

Companies listing this code with FDA

Companies whose registered establishments list this code