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510(k) K920370

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

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)