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

Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl

21 CFR 862.1475 / Clinical Chemistry
FDA source (opens on fda.gov)

LBT is the FDA product code for Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl, a class I device type, regulated under 21 CFR 862.1475. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LBT
Device name
Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl
Regulation
21 CFR 862.1475
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
0

Clearances, product code LBT

By decision year
8 clearances under product code LBT with a decision year between 1979 and 2000, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LBT by decision year
YearClearances
19791
19871
19881
19891
19901
19971
19991
20001

Applicants with the most clearances

Product code LBT
Applicants holding the most 510(k) clearances under product code LBT
ApplicantClearances
Helena Laboratories, Corp.4
Morax2
Gelman Sciences, Inc.1
Roche Diagnostics GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code