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Prosphyg™ 760-11ACMKOIQ

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 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00843515234450 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Prosphyg™
Generic Name
Ophthalmic/otologic diagnostic set
Model / Ref / Catalog
760-11ACMKOIQ
Primary DI / UDI-DI
00843515234450
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)

Show all (12)

Other devices from American Diagnostic Corporation

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Properties

  • Over-the-Counter
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No