510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K761182Substantially Equivalent

Isotonic Diluent Af

Central Labs. Assoc. MD Pathologists, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K761182 is the FDA 510(k) clearance record for ISOTONIC DILUENT AF, a class I device, cleared for Central Labs. Assoc. MD Pathologists on under FDA product code GGK (Products, Red-Cell Lysing Products). FDA records list 3 510(k) clearances for Central Labs. Assoc. MD Pathologists, from to . As of , FDA records show no recalls naming K761182.

Clearance record

Decision date
Received
(7 days to decision)
Product code
GGK Products, Red-Cell Lysing Products
Regulation
21 CFR 864.8540
Device class
Class I
Review panel
Hematology
Applicant
Central Labs. Assoc. MD Pathologists 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