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

Indicator, Sterilization

21 CFR 880.2800 / General Hospital
FDA source (opens on fda.gov)

LRT is the FDA product code for Indicator, Sterilization, a class II device type, regulated under 21 CFR 880.2800. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
LRT
Device name
Indicator, Sterilization
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
5
Ingested recalls
1

Clearances, product code LRT

By decision year
5 clearances under product code LRT with a decision year between 1987 and 2001, 1987 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LRT by decision year
YearClearances
19871
19951
19961
19971
20011

Applicants with the most clearances

Product code LRT
Applicants holding the most 510(k) clearances under product code LRT
ApplicantClearances
Sybron Dental Specialties, Inc.2
Products for Medicine1
Propper Mfg Co Inc1
Steritec Products Mfg. Co., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code