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

U.V. Spectrometry, Theophylline

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

LCY is the FDA product code for U.V. Spectrometry, Theophylline, a class II device type, regulated under 21 CFR 862.3880. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LCY
Device name
U.V. Spectrometry, 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
3
Ingested recalls
0

Clearances, product code LCY

By decision year
3 clearances under product code LCY with a decision year between 1978 and 1989, 1978 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LCY by decision year
YearClearances
19782
19891

Applicants with the most clearances

Product code LCY
Applicants holding the most 510(k) clearances under product code LCY
ApplicantClearances
Syva Co.2
Gds Diagnostics1

Companies listing this code with FDA

Companies whose registered establishments list this code