510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K841114Substantially Equivalent

Allo-Type Human Immunoglobulin-

Immucor GTI Diagnostics, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841114 is the FDA 510(k) clearance record for ALLO-TYPE HUMAN IMMUNOGLOBULIN-, a class I device, cleared for Genetic Testing Institute on under FDA product code DGX (Ng1m(A), Antigen, Antiserum, Control). FDA records list 8 510(k) clearances for Immucor GTI Diagnostics, Inc., from to . As of , FDA records show no recalls naming K841114.

Clearance record

Decision date
Received
(91 days to decision)
Product code
DGX Ng1m(A), Antigen, Antiserum, Control
Regulation
21 CFR 866.5065
Device class
Class I
Review panel
Immunology
Applicant
Genetic Testing Institute 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DGX

Trailing 12 months

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

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