Product code CGM— Immunology

HUMAN IGG SUBCLASS RID KIT

Classification name: Method, Immunodiffusion, Immunoglobulins (G, A, M)
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Total cleared: 4
First cleared: 1992-03-11
Most recent: 1992-03-26

Market context for product code CGM

FDA has cleared 4 devices under product code CGM, all in 1992, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code CGM

Instrumentation Laboratory CO2 clearances
Janssen Biochimica1 clearance
Isotypes, Inc.1 clearance

Recent clearances under product code CGM

K915650 — HUMAN IGG SUBCLASS RID KITJanssen Biochimica·1992-03-26
K920006 — IL TEST IMMUNOGLOBULIN G (IGG)Instrumentation Laboratory CO·1992-03-13
K920008 — IL TEST IMMUNOGLOBULIN M (IGM)Instrumentation Laboratory CO·1992-03-11
K920370 — ISOTYPES HUMAN IGG SUBCLASS EIA KITIsotypes, Inc.·1992-03-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.