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

Antisera, All Types, Escherichia Coli

21 CFR 866.3255 / Microbiology
FDA source (opens on fda.gov)

GNA is the FDA product code for Antisera, All Types, Escherichia Coli, a class I device type, regulated under 21 CFR 866.3255. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
GNA
Device name
Antisera, All Types, Escherichia Coli
Regulation
21 CFR 866.3255
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
12
Ingested recalls
1

Clearances, product code GNA

By decision year
12 clearances under product code GNA with a decision year between 1986 and 2007, 1995 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GNA by decision year
YearClearances
19861
19881
19891
19911
19941
19952
19961
19981
20001
20041
20071

Applicants with the most clearances

Product code GNA
Applicants holding the most 510(k) clearances under product code GNA
ApplicantClearances
Meridian Diagnostics, Inc.2
Oxoid U.S.A., Inc.2
Denka Seiken'S1
EMD Millipore Corporation1
Iverness Medical Professional Diagnostics1
Murex Diagnostics, Inc.1
Oxoid, Ltd.1
Pharmacia, Inc.1
Pro-Lab, Inc.1
Remel Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code