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

Amikacin Serum Assay

21 CFR 862.3035 / Clinical Toxicology
FDA source (opens on fda.gov)

KLP is the FDA product code for Amikacin Serum Assay, a class II device type, regulated under 21 CFR 862.3035. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KLP
Device name
Amikacin Serum Assay
Regulation
21 CFR 862.3035
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
4
Ingested recalls
0

Clearances, product code KLP

By decision year
4 clearances under product code KLP with a decision year between 1978 and 2003, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KLP by decision year
YearClearances
19781
19791
19871
20031

Applicants with the most clearances

Product code KLP
Applicants holding the most 510(k) clearances under product code KLP
ApplicantClearances
BD Becton Dickinson Vacutainer Systems Preanalytic1
Em Diagnostic Systems, Inc.1
Monitor Science Corp.1
Roche Diagnostics GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code