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Immco Diagnostics 2250

by Immco Diagnostics, Inc.

Immco Diagnostics 2250 is a Class II device made by Immco Diagnostics, Inc., cleared under FDA 510(k) K060157 on 25 May 2006 (1 earlier submission) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00845714003943), 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

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00845714003943 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK060157 Date25 May 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K060157 decided 25 May 2006 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00845714003943 listed 23 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K912551
  2. Cleared FDA 510(k) K060157
  3. Listed FDA GUDID 00845714003943

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  • Withdrawn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, control
Model / Ref / Catalog
2250
Primary DI / UDI-DI
00845714003943
510(k) Number
FDA product code
MVM, DBL
GMDN term
Endomysium antibody (EMA) IVD, control
Device class
Class II
Regulation number
866.5660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endomysium antibody (EMA) IVD, control

Cleared under the same submission (K060157)

and 8 more cleared under K060157

Cleared under the same submission (K912551)

and 6 more cleared under K912551

Similar devices

Other devices filed under FDA product code MVM (Autoantibodies, Endomysial(Tissue Transglutaminase)).

Other devices from Immco Diagnostics, Inc.

See all devices from Immco Diagnostics, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)