510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K811178Substantially Equivalent

Human Igg-Albumin Test Kit

Meloy Laboratories, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811178 is the FDA 510(k) clearance record for HUMAN IGG-ALBUMIN TEST KIT, a class II device, cleared for Meloy Laboratories, Inc. on under FDA product code CJQ (Radial Immunodiffusion, Albumin). FDA records list 15 510(k) clearances for Meloy Laboratories, Inc., from to . As of , FDA records show no recalls naming K811178.

Clearance record

Decision date
Received
(17 days to decision)
Product code
CJQ Radial Immunodiffusion, Albumin
Regulation
21 CFR 862.1035
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Meloy Laboratories, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code CJQ

Trailing 12 months

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

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