510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K943098Substantially Equivalent

Human Igg Subclasses Elisa Combi Kit

Research Diagnostics, Inc., Flanders NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943098 is the FDA 510(k) clearance record for HUMAN IGG SUBCLASSES ELISA COMBI KIT, a class I device, cleared for Research Diagnostics, Inc. on under FDA product code DAS (Igg (Fc Fragment Specific), Antigen, Antiserum, Control). FDA records list 3 510(k) clearances for Research Diagnostics, Inc., from to . As of , FDA records show no recalls naming K943098.

Clearance record

Decision date
Received
(71 days to decision)
Product code
DAS Igg (Fc Fragment Specific), Antigen, Antiserum, Control
Regulation
21 CFR 866.5530
Device class
Class I
Review panel
Immunology
Applicant
Research Diagnostics, Inc. Pleasant Hill Rd., Flanders NJ
510(k) summary
Statement
Third party review
No

Clearances, product code DAS

Trailing 12 months

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

FDA records show no clearances under product code DAS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DAS, 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