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

Exoenzymes, Multiple, Streptococcal

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

GTP is the FDA product code for Exoenzymes, Multiple, Streptococcal, a class I device type, regulated under 21 CFR 866.3720. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GTP
Device name
Exoenzymes, Multiple, Streptococcal
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
3
Ingested recalls
0

Clearances, product code GTP

By decision year
3 clearances under product code GTP with a decision year between 1982 and 1986, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GTP by decision year
YearClearances
19821
19831
19861

Applicants with the most clearances

Product code GTP
Applicants holding the most 510(k) clearances under product code GTP
ApplicantClearances
American Scientific Products1
Bio Spec, Inc.1
Cooper Biomedical, 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 GTP.