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

Panels, Test, Susceptibility, Antimicrobial

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

LTT is the FDA product code for Panels, Test, Susceptibility, Antimicrobial, a class II device type, regulated under 21 CFR 866.1640. As of , FDA records hold 50 510(k) clearances under this code, the most recent dated , and 13 recalls.

Classification record

Product code
LTT
Device name
Panels, Test, Susceptibility, 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
50
Ingested recalls
13

Clearances, product code LTT

By decision year
50 clearances under product code LTT with a decision year between 1995 and 2025, 2001 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code LTT by decision year
YearClearances
19953
19962
19972
19982
19991
20001
20017
20027
20033
20041
20062
20092
20101
20111
20132
20151
20174
20191
20204
20253

Applicants with the most clearances

Product code LTT
Applicants holding the most 510(k) clearances under product code LTT
ApplicantClearances
Siemens Healthcare Diagnostics Inc.23
Dade Microscan, Inc.10
Pasco Laboratories, Inc.5
Trek Diagnostic Systems, Ltd.4
Accumed Intl., Inc.3
Baxter Diagnostics, Inc.3
Dade Intl., Inc.1
Siemens Helathcare Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code