510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K842310Substantially Equivalent

Hematology Analyzer

Hml Inc/Biotechnology Transfer, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842310 is the FDA 510(k) clearance record for HEMATOLOGY ANALYZER, a class I device, cleared for Hml Inc/Biotechnology Transfer on under FDA product code JKL (Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry). FDA records list 3 510(k) clearances for Hml Inc/Biotechnology Transfer, from to . As of , FDA records show no recalls naming K842310.

Clearance record

Decision date
Received
(86 days to decision)
Product code
JKL Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry
Regulation
21 CFR 862.1060
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Hml Inc/Biotechnology Transfer 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JKL

Trailing 12 months

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

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