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

Antisera, All Groups, N. Meningitidis

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

GTJ is the FDA product code for Antisera, All Groups, N. Meningitidis, a class II device type, regulated under 21 CFR 866.3390. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
GTJ
Device name
Antisera, 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
16
Ingested recalls
5

Clearances, product code GTJ

By decision year
16 clearances under product code GTJ with a decision year between 1977 and 1996, 1985 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code GTJ by decision year
YearClearances
19771
19821
19831
19842
19854
19862
19871
19891
19911
19921
19961

Applicants with the most clearances

Product code GTJ
Applicants holding the most 510(k) clearances under product code GTJ
ApplicantClearances
Wellcome Diagnostics5
Armkel, LLC3
BD Becton Dickinson Vacutainer Systems Preanalytic3
Pharmacia, Inc.2
Burroughs Wellcome Co.1
Microscan Div. Baxter Healthcare Corp.1
Vitek Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code