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510(k) K920370

ISOTYPES HUMAN IGG SUBCLASS EIA KIT by Isotypes, Inc. — Product Code CGM

K920370 is an FDA 510(k) premarket notification submitted by Isotypes, Inc. for the device "ISOTYPES HUMAN IGG SUBCLASS EIA KIT". The FDA issued a decision of Substantially Equivalent on March 11, 1992. The device falls under product code CGM (Method, Immunodiffusion, Immunoglobulins (G, A, M)), a Class II device regulated under 21 CFR 866.5510.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1992
Date Received
January 28, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Method, Immunodiffusion, Immunoglobulins (G, A, M)
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances for product code CGM

  • K915650 — HUMAN IGG SUBCLASS RID KIT (March 26, 1992)
  • K920006 — IL TEST IMMUNOGLOBULIN G (IGG) (March 13, 1992)
  • K920008 — IL TEST IMMUNOGLOBULIN M (IGM) (March 11, 1992)

FDA data resources