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

Fluorescent Immunoassay, Tobramycin

21 CFR 862.3900 / Clinical Toxicology
FDA source (opens on fda.gov)

LCR is the FDA product code for Fluorescent Immunoassay, Tobramycin, a class II device type, regulated under 21 CFR 862.3900. As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LCR
Device name
Fluorescent Immunoassay, Tobramycin
Regulation
21 CFR 862.3900
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
17
Ingested recalls
0

Clearances, product code LCR

By decision year
17 clearances under product code LCR with a decision year between 1980 and 2006, 1982 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code LCR by decision year
YearClearances
19802
19811
19824
19831
19841
19851
19861
19912
19951
19961
19981
20061

Applicants with the most clearances

Product code LCR
Applicants holding the most 510(k) clearances under product code LCR
ApplicantClearances
Abbott Medical1
American Dade1
American Diagnostic Corp.1
Beckman Instruments, Inc.1
Chiron Diagnostics Corp.1
Dade Intl., Inc.1
E.I. Dupont de Nemours & Co., Inc.1
Electro-Nucleonics Laboratories, Inc.1
Exmoor Plastics Limited1
Intl. Diagnostic Technology1

Companies listing this code with FDA

Companies whose registered establishments list this code