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

Cyclosporine Radioimmunoassay

21 CFR 862.1235 / Clinical Chemistry
FDA source (opens on fda.gov)

LTB is the FDA product code for Cyclosporine Radioimmunoassay, a class II device type, regulated under 21 CFR 862.1235. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
LTB
Device name
Cyclosporine Radioimmunoassay
Regulation
21 CFR 862.1235
Device class
Class II
Review panel
Clinical Chemistry
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 LTB

By decision year
1 clearance under product code LTB with a decision year between 1981 and 1981, 1981 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LTB by decision year
YearClearances
19811

Applicants with the most clearances

Product code LTB
Applicants holding the most 510(k) clearances under product code LTB
ApplicantClearances
Techhnilab Instruments, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code