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

Antisera, Fluorescent, All Types, Escherichia Coli

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

GMY is the FDA product code for Antisera, Fluorescent, All Types, Escherichia Coli, a class I device type, regulated under 21 CFR 866.3255. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GMY
Device name
Antisera, Fluorescent, 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
2
Ingested recalls
0

Clearances, product code GMY

By decision year
2 clearances under product code GMY with a decision year between 1977 and 1977, 1977 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GMY by decision year
YearClearances
19772

Applicants with the most clearances

Product code GMY
Applicants holding the most 510(k) clearances under product code GMY
ApplicantClearances
Pfizer Pharmaceuticals1
Pfizer Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code