510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881261Substantially Equivalent

Bion Hsv1-G or Hsv2-G Test System

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

K881261 is the FDA 510(k) clearance record for BION HSV1-G OR HSV2-G TEST SYSTEM, a class II device, cleared for Bion Ent., Ltd. on under FDA product code GQO (Antisera, Cf, Herpesvirus Hominis 1,2). FDA records list 14 510(k) clearances for Bion Ent., Ltd., from to . As of , FDA records show one recall naming K881261.

Clearance record

Decision date
Received
(75 days to decision)
Product code
GQO Antisera, Cf, Herpesvirus Hominis 1,2
Regulation
21 CFR 866.3305
Device class
Class II
Review panel
Microbiology
Applicant
Bion Ent., Ltd. 674 Busse Hwy., Park Ridge IL
Third party review
No

Clearances, product code GQO

Trailing 12 months

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

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