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

Antisera, Fluorescent, All Types, Staphylococcus Spp.

21 CFR 866.3700 / Microbiology
FDA source (opens on fda.gov)

GTN is the FDA product code for Antisera, Fluorescent, All Types, Staphylococcus Spp., a class I device type, regulated under 21 CFR 866.3700. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GTN
Device name
Antisera, Fluorescent, All Types, Staphylococcus Spp.
Regulation
21 CFR 866.3700
Device class
Class I
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code GTN

By decision year
4 clearances under product code GTN with a decision year between 1979 and 1986, 1986 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GTN by decision year
YearClearances
19791
19851
19862

Applicants with the most clearances

Product code GTN
Applicants holding the most 510(k) clearances under product code GTN
ApplicantClearances
Oxoid U.S.A., Inc.2
Volu Sol Medical Industries1
Wellcome Diagnostics1

Companies listing this code with FDA

Companies whose registered establishments list this code