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

Reagent, Leishmanii Serological

21 CFR 866.3870 / Microbiology
FDA source (opens on fda.gov)

LOO is the FDA product code for Reagent, Leishmanii Serological, a class I device type, regulated under 21 CFR 866.3870. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LOO
Device name
Reagent, Leishmanii Serological
Regulation
21 CFR 866.3870
Device class
Class I
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code LOO

By decision year
2 clearances under product code LOO with a decision year between 1984 and 2003, 1984 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LOO by decision year
YearClearances
19841
20031

Applicants with the most clearances

Product code LOO
Applicants holding the most 510(k) clearances under product code LOO
ApplicantClearances
Amico Lab, Inc.1
Inbios Intl., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code