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

Oxyhemoglobin

21 CFR 864.7500 / Hematology
FDA source (opens on fda.gov)

GGZ is the FDA product code for Oxyhemoglobin, a class II device type, regulated under 21 CFR 864.7500. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GGZ
Device name
Oxyhemoglobin
Regulation
21 CFR 864.7500
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code GGZ

By decision year
2 clearances under product code GGZ with a decision year between 2018 and 2020, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GGZ by decision year
YearClearances
20181
20201

Applicants with the most clearances

Product code GGZ
Applicants holding the most 510(k) clearances under product code GGZ
ApplicantClearances
Nova Biomedical Corporation2

Companies listing this code with FDA

Companies whose registered establishments list this code