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

Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control

21 CFR 866.5100 / Immunology
FDA source (opens on fda.gov)

LRM is the FDA product code for Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control, a class II device type, regulated under 21 CFR 866.5100. As of , FDA records hold 29 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
LRM
Device name
Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
29
Ingested recalls
3

Clearances, product code LRM

By decision year
29 clearances under product code LRM with a decision year between 1987 and 2010, 1995 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code LRM by decision year
YearClearances
19872
19891
19901
19912
19921
19941
19954
19963
19972
19984
19991
20003
20041
20061
20091
20101

Applicants with the most clearances

Product code LRM
Applicants holding the most 510(k) clearances under product code LRM
ApplicantClearances
Diamedix Corp.3
Elias U.S.A., Inc.2
Helix Diagnostics, Inc.2
Hycor Biomedical2
The Binding Site2
3M Diagnostic Systems, Inc.1
American Laboratory Products Company1
Amersham Corp.1
Bio-Rad1
Cambridge Life Sciences PLC.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order