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Adstation™ 56102B-356LEU

by American Diagnostic Corporation

Adstation™ 56102B-356LEU is a Class II device made by American Diagnostic Corporation, cleared under FDA 510(k) K950914 on 24 Jul 1995 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 00634782077501), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K950914

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00634782077501 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK950914 Date24 Jul 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K950914 decided 24 Jul 1995 Active
  • FDA GUDID UDI-DI 00634782077501 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K950914
  2. Listed FDA GUDID 00634782077501

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Adstation™
Generic name
Ophthalmic/otologic diagnostic set
Model / Ref / Catalog
56102B-356LEU
Primary DI / UDI-DI
00634782077501
510(k) Number
FDA product code
HLJ
GMDN term
Ophthalmic/otologic diagnostic set
Device class
Class II
Regulation number
886.1570
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ophthalmic/otologic diagnostic set

Cleared under the same submission (K950914)

and 8 more cleared under K950914

Similar devices

Other devices filed under FDA product code HLJ (Ophthalmoscope, Battery-Powered).

Other devices from American Diagnostic Corporation

See all devices from American Diagnostic Corporation →

Properties

  • Over-the-counter
  • Convenience kit
  • Lot / batch number
Other properties (12, all answered No)