510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K812664Substantially Equivalent

Aca Immunoglobulin G Analytical Test

E.I. Dupont de Nemours & Co., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812664 is the FDA 510(k) clearance record for ACA IMMUNOGLOBULIN G ANALYTICAL TEST, a class II device, cleared for E.I. Dupont DE Nemours & Co., Inc. on under FDA product code DEW (Igg, Antigen, Antiserum, Control). FDA records list 253 510(k) clearances for E.I. Dupont DE Nemours & Co., Inc., from to . As of , FDA records show no recalls naming K812664.

Clearance record

Decision date
Received
(11 days to decision)
Product code
DEW Igg, Antigen, Antiserum, Control
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
E.I. Dupont DE Nemours & Co., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DEW

Trailing 12 months

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

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