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Immco Diagnostics 2213

by Immco Diagnostics, Inc.

Immco Diagnostics 2213 is a Class II device made by Immco Diagnostics, Inc., cleared under FDA 510(k) K891098 on 22 Mar 1989 (1 earlier submission) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00845714003257), 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 Number00845714003257 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK891098 Date22 Mar 1989DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K891098 decided 22 Mar 1989 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00845714003257 listed 23 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K891098
  2. Cleared FDA 510(k) K891099
  3. Listed FDA GUDID 00845714003257

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  • Withdrawn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
Skin antibody IVD, kit, fluorescent immunoassay
Model / Ref / Catalog
2213
Primary DI / UDI-DI
00845714003257
510(k) Number
FDA product code
DBL
GMDN term
Skin antibody IVD, kit, fluorescent immunoassay
Device class
Class II
Regulation number
866.5660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Skin antibody IVD, kit, fluorescent immunoassay

Cleared under the same submission (K891098)

and 8 more cleared under K891098

Cleared under the same submission (K891099)

and 8 more cleared under K891099

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)