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Immco Diagnostics 2113X

by Immco Diagnostics, Inc.

Immco Diagnostics 2113X is a Class II device made by Immco Diagnostics, Inc., cleared under FDA 510(k) K913360 on 26 Sep 1994 (1 earlier submission) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00845714003059), 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 Number00845714003059 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· +1 more in the status table
  • FDA GUDID UDI-DI 00845714003059 listed 23 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K912551
  2. Cleared FDA 510(k) K913360
  3. Listed FDA GUDID 00845714003059

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  • Withdrawn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
Human immunoglobulin A (IgA)/IgG/IgM animal conjugate antibody reagent IVD
Model / Ref / Catalog
2113X
Primary DI / UDI-DI
00845714003059
510(k) Number
FDA product code
DBL
GMDN term
Human immunoglobulin A (IgA)/IgG/IgM animal conjugate antibody reagent IVD
Device class
Class II
Regulation number
866.5660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Human immunoglobulin A (IgA)/IgG/IgM animal conjugate antibody reagent IVD

Cleared under the same submission (K912551)

and 6 more cleared under K912551

Cleared under the same submission (K913360)

and 5 more cleared under K913360

Similar devices

Other devices filed under FDA product code DBL (Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control).

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)