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Immco Diagnostics 2251

by Immco Diagnostics, Inc.

Immco Diagnostics 2251 is a Class II device made by Immco Diagnostics, Inc., cleared under FDA 510(k) K913360 on 26 Sep 1994 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00845714003974), 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) K913360

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 Number00845714003974 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK913360 Date26 Sep 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K913360 decided 26 Sep 1994 Active
  • FDA GUDID UDI-DI 00845714003974 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K913360
  2. Listed FDA GUDID 00845714003974

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Immco Diagnostics
Generic name
Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay
Model / Ref / Catalog
2251
Primary DI / UDI-DI
00845714003974
510(k) Number
FDA product code
DBL
GMDN term
Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay
Device class
Class II
Regulation number
866.5660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay

Cleared under the same submission (K913360)

and 5 more cleared under K913360

Other devices from Immco Diagnostics, Inc.

See all devices from Immco Diagnostics, Inc. →

Properties

  • Prescription use
  • Combination product
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)