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

Method, Immunodiffusion, Immunoglobulins (G, A, M)

21 CFR 866.5510 / Immunology
FDA source (opens on fda.gov)

CGM is the FDA product code for Method, Immunodiffusion, Immunoglobulins (G, A, M), a class II device type, regulated under 21 CFR 866.5510. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
CGM
Device name
Method, Immunodiffusion, Immunoglobulins (G, A, M)
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
4
Ingested recalls
0

Clearances, product code CGM

By decision year
4 clearances under product code CGM with a decision year between 1992 and 1992, 1992 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code CGM by decision year
YearClearances
19924

Applicants with the most clearances

Product code CGM
Applicants holding the most 510(k) clearances under product code CGM
ApplicantClearances
Instrumentation Laboratory Co.2
Isotypes, Inc.1
Janssen Biochimica1

Companies listing this code with FDA

Companies whose registered establishments list this code