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
K850683Substantially Equivalent

72 Determ. Size Radial Immunodiffusion Test Alpha2

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

K850683 is the FDA 510(k) clearance record for 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2, a class II device, cleared for Kent Laboratories, Inc. on under FDA product code DEB (Alpha-2-Macroglobulin, Antigen, Antiserum, Control). FDA records list 40 510(k) clearances for Kent Laboratories, Inc., from to . As of , FDA records show no recalls naming K850683.

Clearance record

Decision date
Received
(279 days to decision)
Product code
DEB Alpha-2-Macroglobulin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5620
Device class
Class II
Review panel
Immunology
Applicant
Kent Laboratories, Inc. 23404 NE 8th St., Redmond WA
Third party review
No

Clearances, product code DEB

Trailing 12 months

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

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