Skip to content

Ebv-Ebna Igg Elisa Kit, Model Ebg-100

by Pan Bio Pty., Ltd.

510(k) K020707

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 11 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK020707 Date13 Jun 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 11 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GNP
FDA applicant
Pan Bio Pty. , Ltd.
Device Class
Class I
Regulation
21 CFR Part 866.3235
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Other devices from Pan Bio Pty., Ltd.