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

Control, Hemoglobin

21 CFR 864.8625 / Hematology
FDA source (opens on fda.gov)

GGM is the FDA product code for Control, Hemoglobin, a class II device type, regulated under 21 CFR 864.8625. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
GGM
Device name
Control, Hemoglobin
Regulation
21 CFR 864.8625
Device class
Class II
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
15
Ingested recalls
2

Clearances, product code GGM

By decision year
15 clearances under product code GGM with a decision year between 1979 and 2019, 1996 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GGM by decision year
YearClearances
19791
19801
19851
19891
19921
19962
19991
20001
20031
20051
20072
20192

Applicants with the most clearances

Product code GGM
Applicants holding the most 510(k) clearances under product code GGM
ApplicantClearances
R & D Systems, Inc.3
Bio-Rad2
Direct Solutions2
Eurotrol B.V.2
Bio-Rad Laboratories Inc.1
Boehringer Mannheim Corp.1
Dade, Baxter Travenol Diagnostics, Inc.1
Electrophoresis Corp.1
Isolab, Inc.1
Quantimetrix Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order