510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K831960Substantially Equivalent

Test for Human Alpha One Acid Glyco-

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

K831960 is the FDA 510(k) clearance record for TEST FOR HUMAN ALPHA ONE ACID GLYCO-, a class I device, cleared for Kent Laboratories, Inc. on under FDA product code LKL (Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control). FDA records list 40 510(k) clearances for Kent Laboratories, Inc., from to . As of , FDA records show no recalls naming K831960.

Clearance record

Decision date
Received
(32 days to decision)
Product code
LKL Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
Regulation
21 CFR 866.5420
Device class
Class I
Review panel
Immunology
Applicant
Kent Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LKL

Trailing 12 months

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

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