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Diagnostix™ 5160NBD

by American Diagnostic Corporation

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00634782086848 UDI-DI Date15 May 2019ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Diagnostix™
Generic Name
Ophthalmic/otologic diagnostic set
Model / Ref / Catalog
5160NBD
Primary DI / UDI-DI
00634782086848
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 (K093495)

Show all (12)

Other devices from American Diagnostic Corporation

See all devices from American Diagnostic Corporation →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No