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

Antigens, All Groups, Streptococcus Spp.

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

GTY is the FDA product code for Antigens, All Groups, Streptococcus Spp., a class I device type, regulated under 21 CFR 866.3740. As of , FDA records hold 44 510(k) clearances under this code, the most recent dated , and 20 recalls.

Classification record

Product code
GTY
Device name
Antigens, 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
44
Ingested recalls
20

Clearances, product code GTY

By decision year
44 clearances under product code GTY with a decision year between 1981 and 2026, 1984 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code GTY by decision year
YearClearances
19811
19832
19844
19863
19871
19881
19901
19912
19922
19942
19951
19971
19981
19992
20002
20013
20021
20032
20041
20051
20081
20091
20132
20142
20171
20221
20251
20261

Applicants with the most clearances

Product code GTY
Applicants holding the most 510(k) clearances under product code GTY
ApplicantClearances
Ortho-Clinical Diagnostics, Inc.5
Acon Laboratories, Inc.4
Princeton BioMeditech Corp.4
SA Scientific, Ltd3
Scientific Device Laboratory, Inc.3
Abbott Medical2
Biostar, Inc.2
Pharmacia, Inc.2
BD Becton Dickinson Vacutainer Systems Preanalytic1
Becton Dickinson Advanced Diagnostics1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 45 companies shown, in name order