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
K852343Substantially Equivalent

Dig Radioimmunoassay Test System

M Nobird, Inc., Costa Mesa CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852343 is the FDA 510(k) clearance record for DIG RADIOIMMUNOASSAY TEST SYSTEM, a class II device, cleared for M Nobird, Inc. on under FDA product code DNL (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.). FDA records list one 510(k) clearance for M Nobird, Inc. As of , FDA records show no recalls naming K852343.

Clearance record

Decision date
Received
(36 days to decision)
Product code
DNL Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.
Regulation
21 CFR 862.3320
Device class
Class II
Review panel
Clinical Toxicology
Applicant
M Nobird, Inc. 729 W. 16th St., C-4, Costa Mesa CA
Third party review
No

Clearances, product code DNL

Trailing 12 months

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

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