510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K810871Substantially Equivalent

Lightning Dialyzer

Clintox Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810871 is the FDA 510(k) clearance record for LIGHTNING DIALYZER, a class I device, cleared for Clintox Laboratories, Inc. on under FDA product code DHY (Ng4m(A), Antigen, Antiserum, Control). FDA records list one 510(k) clearance for Clintox Laboratories, Inc. As of , FDA records show no recalls naming K810871.

Clearance record

Decision date
Received
(101 days to decision)
Product code
DHY Ng4m(A), Antigen, Antiserum, Control
Regulation
21 CFR 866.5065
Device class
Class I
Review panel
Immunology
Applicant
Clintox Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DHY

Trailing 12 months

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

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