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
K011348Substantially Equivalent

Phase II Gbm Igg Antibody Eia Test

Scimedx Corp., Denvill NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011348 is the FDA 510(k) clearance record for PHASE II GBM IGG ANTIBODY EIA TEST, a class II device, cleared for Scimedx Corp. on under FDA product code MVJ (Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)). FDA records list 14 510(k) clearances for Scimedx Corp., from to . As of , FDA records show no recalls naming K011348.

Clearance record

Decision date
Received
(54 days to decision)
Product code
MVJ Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Applicant
Scimedx Corp. 400 Ford Rd., Denvill NJ
510(k) summary
Statement
Third party review
No

Clearances, product code MVJ

Trailing 12 months

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

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