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

Antigens, Slide And Tube, All Types, Listeria Monocytogenes

21 CFR 866.3355 / Microbiology
FDA source (opens on fda.gov)

GSI is the FDA product code for Antigens, Slide And Tube, All Types, Listeria Monocytogenes, a class I device type, regulated under 21 CFR 866.3355. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
GSI
Device name
Antigens, Slide And Tube, All Types, Listeria Monocytogenes
Regulation
21 CFR 866.3355
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
1
Ingested recalls
0

Clearances, product code GSI

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

Applicants with the most clearances

Product code GSI
Applicants holding the most 510(k) clearances under product code GSI
ApplicantClearances
Scientific Device Laboratory, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

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