510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983390Substantially Equivalent

Is-Anti-Mpo Igg Elisa Test System

Columbia Bioscience, Inc., Columbia MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983390 is the FDA 510(k) clearance record for IS-ANTI-MPO IGG ELISA TEST SYSTEM, a class II device, cleared for Columbia Bioscience, Inc. on under FDA product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)). FDA records list 13 510(k) clearances for Columbia Bioscience, Inc., from to . As of , FDA records show no recalls naming K983390.

Clearance record

Decision date
Received
(54 days to decision)
Product code
MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Applicant
Columbia Bioscience, Inc. 8775 M Centre Park Dr., Columbia MD
510(k) summary
Summary
Third party review
No

Clearances, product code MOB

Trailing 12 months
1 clearance under product code MOB in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MOB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260