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

Thin Layer Chromatography, Theophylline

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

LEW is the FDA product code for Thin Layer Chromatography, Theophylline, a class II device type, regulated under 21 CFR 862.3880. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
LEW
Device name
Thin Layer Chromatography, 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
1
Ingested recalls
0

Clearances, product code LEW

By decision year
1 clearance under product code LEW with a decision year between 1977 and 1977, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LEW by decision year
YearClearances
19771

Applicants with the most clearances

Product code LEW
Applicants holding the most 510(k) clearances under product code LEW
ApplicantClearances
Espe Dental Products1

Companies listing this code with FDA

Companies whose registered establishments list this code

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