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

Oximeter To Measure Hemoglobin

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

GLY is the FDA product code for Oximeter To Measure Hemoglobin, a class II device type, regulated under 21 CFR 864.7500. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GLY
Device name
Oximeter To Measure Hemoglobin
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
5
Ingested recalls
0

Clearances, product code GLY

By decision year
5 clearances under product code GLY with a decision year between 1989 and 2005, 1996 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GLY by decision year
YearClearances
19891
19962
19991
20051

Applicants with the most clearances

Product code GLY
Applicants holding the most 510(k) clearances under product code GLY
ApplicantClearances
Nova Biomedical Corporation2
Avl Scientific Corp.1
Nir Diagnostics, Inc.1
Radiometer America, Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code