ISOTYPES HUMAN IGG SUBCLASS EIA KIT— 510(k) K920370

Name: FDA 510(k) clearance K920370
Creator: U.S. Food and Drug Administration
Published: 1992-03-11

Substantially Equivalent

Isotypes, Inc.

FDA 510(k) clearance K920370 for ISOTYPES HUMAN IGG SUBCLASS EIA KIT, Substantially Equivalent on 1992-03-11. Applicant: Isotypes, Inc.. Device class: 2.

Clearance details

Applicant: Isotypes, Inc.
Product code: Code CGM
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1992-01-28
Decision date: 1992-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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Recent devices under product code CGM

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K915650 — HUMAN IGG SUBCLASS RID KIT1992-03-26
K920006 — IL TEST IMMUNOGLOBULIN G (IGG)1992-03-13
K920008 — IL TEST IMMUNOGLOBULIN M (IGM)1992-03-11

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