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

Antisera, Fluorescent, All Groups, Streptococcus Spp.

21 CFR 866.3740 / Microbiology
FDA source (opens on fda.gov)

GTX is the FDA product code for Antisera, Fluorescent, All Groups, Streptococcus Spp., a class I device type, regulated under 21 CFR 866.3740. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GTX
Device name
Antisera, Fluorescent, All Groups, Streptococcus Spp.
Regulation
21 CFR 866.3740
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
2
Ingested recalls
0

Clearances, product code GTX

By decision year
2 clearances under product code GTX with a decision year between 1980 and 1981, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GTX by decision year
YearClearances
19801
19811

Applicants with the most clearances

Product code GTX
Applicants holding the most 510(k) clearances under product code GTX
ApplicantClearances
Clinical Sciences, Inc.1
Springwood Microbiologicals1

Companies listing this code with FDA

Companies whose registered establishments list this code

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