510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880679Substantially Equivalent

Bion Cmv-G Test System

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

K880679 is the FDA 510(k) clearance record for BION CMV-G TEST SYSTEM, a class II device, cleared for Bion Ent., Ltd. on under FDA product code GQH (Antigen, Cf (Including Cf Control), Cytomegalovirus). FDA records list 14 510(k) clearances for Bion Ent., Ltd., from to . As of , FDA records show one recall naming K880679.

Clearance record

Decision date
Received
(105 days to decision)
Product code
GQH Antigen, Cf (Including Cf Control), Cytomegalovirus
Regulation
21 CFR 866.3175
Device class
Class II
Review panel
Microbiology
Applicant
Bion Ent., Ltd. 674 Busse Hwy., Park Ridge IL
Third party review
No

Clearances, product code GQH

Trailing 12 months

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

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