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

Test, Sickle Cell

21 CFR 864.7825 / Hematology
FDA source (opens on fda.gov)

GHM is the FDA product code for Test, Sickle Cell, a class II device type, regulated under 21 CFR 864.7825. As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
GHM
Device name
Test, Sickle Cell
Regulation
21 CFR 864.7825
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
18
Ingested recalls
5

Clearances, product code GHM

By decision year
18 clearances under product code GHM with a decision year between 1979 and 2002, 1984 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code GHM by decision year
YearClearances
19791
19811
19821
19831
19845
19851
19862
19871
19912
19961
20011
20021

Applicants with the most clearances

Product code GHM
Applicants holding the most 510(k) clearances under product code GHM
ApplicantClearances
Isolab, Inc.4
Anco Medical Reagents & Assoc.2
MichClone Associates, Inc.2
Pacific Hemostasis2
Streck Laboratories, Inc.2
Clinical Technology Inc.1
Livonia Diagnostics, Inc.1
Panmed, Inc.1
SA Scientific, Ltd1
Sherwood Medical Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code