510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K832182Substantially Equivalent

Lysing Reagent

Omega Medical Diagnostics, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832182 is the FDA 510(k) clearance record for LYSING REAGENT, a class I device, cleared for Omega Medical Diagnostics on under FDA product code GGK (Products, Red-Cell Lysing Products). FDA records list 5 510(k) clearances for Omega Medical Diagnostics, from to . As of , FDA records show no recalls naming K832182.

Clearance record

Decision date
Received
(36 days to decision)
Product code
GGK Products, Red-Cell Lysing Products
Regulation
21 CFR 864.8540
Device class
Class I
Review panel
Hematology
Applicant
Omega Medical Diagnostics 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GGK

Trailing 12 months

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

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