510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
KLBClass II

Radioimmunoassay, Tobramycin

21 CFR 862.3900 / Clinical Toxicology
FDA source (opens on fda.gov)

KLB is the FDA product code for Radioimmunoassay, Tobramycin, a class II device type, regulated under 21 CFR 862.3900. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
KLB
Device name
Radioimmunoassay, Tobramycin
Regulation
21 CFR 862.3900
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
23
Ingested recalls
2

Clearances, product code KLB

By decision year
23 clearances under product code KLB with a decision year between 1976 and 2006, 1981 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KLB by decision year
YearClearances
19761
19781
19793
19801
19814
19821
19831
19841
19852
19871
19881
19891
19902
20012
20061

Applicants with the most clearances

Product code KLB
Applicants holding the most 510(k) clearances under product code KLB
ApplicantClearances
Siemens Healthcare Diagnostics Inc.3
E.I. Dupont de Nemours & Co., Inc.3
Bio-Rad2
Syva Co.2
Alpha Gamma Laboratory1
Antibodies, Inc.1
BD Becton Dickinson Vacutainer Systems Preanalytic1
Biosan Laboratories, Inc.1
Clinical Assays, Inc.1
Clinical Data, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code