510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920370Substantially Equivalent

Isotypes Human Igg Subclass Eia Kit

Isotypes, Inc., Newark DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920370 is the FDA 510(k) clearance record for ISOTYPES HUMAN IGG SUBCLASS EIA KIT, a class II device, cleared for Isotypes, Inc. on under FDA product code CGM (Method, Immunodiffusion, Immunoglobulins (G, A, M)). FDA records list one 510(k) clearance for Isotypes, Inc. As of , FDA records show no recalls naming K920370.

Clearance record

Decision date
Received
(43 days to decision)
Product code
CGM Method, Immunodiffusion, Immunoglobulins (G, A, M)
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Isotypes, Inc. P.O. Box 7022, Newark DE
510(k) summary
Summary
Third party review
No

Clearances, product code CGM

Trailing 12 months

FDA records hold no clearances under product code CGM in the trailing twelve months.

FDA records show no clearances under product code CGM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CGM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260