510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K926066Substantially Equivalent

Bion Mumps-G Antibody Test System

Bion Ent., Ltd., Park Ridge IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K926066 is the FDA 510(k) clearance record for BION MUMPS-G ANTIBODY TEST SYSTEM, a class II device, cleared for Bion Ent., Ltd. on under FDA product code CAR (Monitor, Spinal-Fluid Pressure, Electrically Powered). FDA records list 14 510(k) clearances for Bion Ent., Ltd., from to . As of , FDA records show one recall naming K926066.

Clearance record

Decision date
Received
(196 days to decision)
Product code
CAR Monitor, Spinal-Fluid Pressure, Electrically Powered
Regulation
21 CFR 880.2460
Device class
Class II
Review panel
General Hospital
Applicant
Bion Ent., Ltd. 674 Busse Hwy., Park Ridge IL
510(k) summary
Summary
Third party review
No

Clearances, product code CAR

Trailing 12 months

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

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