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

Fluorescent Immunoassay, Theophylline

21 CFR 862.3880 / Clinical Toxicology
FDA source (opens on fda.gov)

LER is the FDA product code for Fluorescent Immunoassay, Theophylline, a class II device type, regulated under 21 CFR 862.3880. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
LER
Device name
Fluorescent Immunoassay, Theophylline
Regulation
21 CFR 862.3880
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
15
Ingested recalls
1

Clearances, product code LER

By decision year
15 clearances under product code LER with a decision year between 1981 and 1994, 1981 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code LER by decision year
YearClearances
19814
19821
19833
19842
19862
19881
19901
19941

Applicants with the most clearances

Product code LER
Applicants holding the most 510(k) clearances under product code LER
ApplicantClearances
Miles Laboratories, Inc.3
3M Company1
Abbott Medical1
American Diagnostic Corp.1
Bio-Rad1
Hoffmann-La Roche, Inc.1
Microgenics Corporation1
Paragon Diagnostics, Inc.1
Sclavo, Inc.1
Sigma Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code LER.