510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K940183Substantially Equivalent

Hy-Tec Total Ige Enzyme Immunoassay

Hycor Biomedical, Garden Grove CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940183 is the FDA 510(k) clearance record for HY-TEC TOTAL IGE ENZYME IMMUNOASSAY, a class II device, cleared for Hycor Biomedical, Inc. on under FDA product code DGC (Ige, Antigen, Antiserum, Control). FDA records list 66 510(k) clearances for Hycor Biomedical, Inc., from to . As of , FDA records show no recalls naming K940183.

Clearance record

Decision date
Received
(125 days to decision)
Product code
DGC Ige, Antigen, Antiserum, Control
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Hycor Biomedical, Inc. 7572 Chapman Ave., Garden Grove CA
510(k) summary
Summary
Third party review
No

Clearances, product code DGC

Trailing 12 months

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

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