Skip to content

Sample preservation solution

by Zhejiang Gene Science Co., Ltd. 510(k)

Active United States

510(k) K212878

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK212878 Date8 Apr 2024ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 10 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
QBD
Device Class
Class II
Regulation
21 CFR Part 866.2950
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Other devices from Zhejiang Gene Science Co., Ltd.