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
GTIClass II

Antisera, Fluorescent, All Groups, N. Meningitidis

21 CFR 866.3390 / Microbiology
FDA source (opens on fda.gov)

GTI is the FDA product code for Antisera, Fluorescent, All Groups, N. Meningitidis, a class II device type, regulated under 21 CFR 866.3390. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GTI
Device name
Antisera, Fluorescent, All Groups, N. Meningitidis
Regulation
21 CFR 866.3390
Device class
Class II
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 GTI

By decision year
2 clearances under product code GTI with a decision year between 1984 and 1992, 1984 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GTI by decision year
YearClearances
19841
19921

Applicants with the most clearances

Product code GTI
Applicants holding the most 510(k) clearances under product code GTI
ApplicantClearances
BD Becton Dickinson Vacutainer Systems Preanalytic2

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code GTI.