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

Antideoxyribonuclease, Streptococcus Spp.

21 CFR 866.3720 / Microbiology
FDA source (opens on fda.gov)

GTR is the FDA product code for Antideoxyribonuclease, Streptococcus Spp., a class I device type, regulated under 21 CFR 866.3720. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
GTR
Device name
Antideoxyribonuclease, Streptococcus Spp.
Regulation
21 CFR 866.3720
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 GTR

By decision year
1 clearance under product code GTR with a decision year between 1979 and 1979, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GTR by decision year
YearClearances
19791

Applicants with the most clearances

Product code GTR
Applicants holding the most 510(k) clearances under product code GTR
ApplicantClearances
Calbiochem-Behring Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code