Skip to content

Eyeglasses Frames

by Vistula Assistance & Consulting Bureau

510(k) K933529

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK933529 Date20 Oct 1993ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0277-05 FDA Unclassified (pre-2012) initiated 6 Oct 2004 on shared 510(k) K933529

    Poor sealing of pouches and degradation of products. Firm received an e-mail from a distributor of an increase in complaints. In response to the complaints, the distributor conducted its own functional testing and noticed a degradation in performance of the two lots. Chembio's investigation revealed invalid results (no control lines) and some false negatives.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
HQZ
Device Class
Class I
Regulation
21 CFR Part 886.5842
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent