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

Assay, Carboxyhemoglobin

21 CFR 864.7425 / Hematology
FDA source (opens on fda.gov)

GHS is the FDA product code for Assay, Carboxyhemoglobin, a class II device type, regulated under 21 CFR 864.7425. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GHS
Device name
Assay, Carboxyhemoglobin
Regulation
21 CFR 864.7425
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 GHS

By decision year
5 clearances under product code GHS with a decision year between 1977 and 1998, 1977 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GHS by decision year
YearClearances
19772
19791
19911
19981

Applicants with the most clearances

Product code GHS
Applicants holding the most 510(k) clearances under product code GHS
ApplicantClearances
Corning Medical & Scientific1
Iadec, Inc.1
Bio-Logic Systems Corp.1
Radiometer America, Inc1
The London Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code