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

Susceptibility Test Cards, Antimicrobial

21 CFR 866.1640 / Microbiology
FDA source (opens on fda.gov)

LTW is the FDA product code for Susceptibility Test Cards, Antimicrobial, a class II device type, regulated under 21 CFR 866.1640. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and 39 recalls.

Classification record

Product code
LTW
Device name
Susceptibility Test Cards, Antimicrobial
Regulation
21 CFR 866.1640
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
16
Ingested recalls
39

Clearances, product code LTW

By decision year
16 clearances under product code LTW with a decision year between 1984 and 1985, 1985 the highest year at 13.
Show the numbers
510(k) clearances under FDA product code LTW by decision year
YearClearances
19843
198513

Applicants with the most clearances

Product code LTW
Applicants holding the most 510(k) clearances under product code LTW
ApplicantClearances
Austin Biological Laboratories11
Analytical Products, Inc.3
BD Becton Dickinson Vacutainer Systems Preanalytic1
Microtech Medical Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code