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Immco Diagnostics 2215

by Immco Diagnostics, Inc.

Immco Diagnostics 2215 is a Class II device made by Immco Diagnostics, Inc., cleared under FDA 510(k) K884400 on 4 Nov 1988 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00845714003677), 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) K884400

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 Number00845714003677 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK884400 Date4 Nov 1988DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K884400 decided 4 Nov 1988 Active
  • FDA GUDID UDI-DI 00845714003677 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K884400
  2. Listed FDA GUDID 00845714003677

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  • Withdrawn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
Double stranded DNA antibody (anti-dsDNA) IVD, reagent
Model / Ref / Catalog
2215
Primary DI / UDI-DI
00845714003677
510(k) Number
FDA product code
DHN
GMDN term
Double stranded DNA antibody (anti-dsDNA) IVD, reagent
Device class
Class II
Regulation number
866.5100
GUDID distribution status
In Commercial Distribution

Related devices

Category: Double stranded DNA antibody (anti-dsDNA) IVD, reagent

Cleared under the same submission (K884400)

and 6 more cleared under K884400

Similar devices

Other devices filed under FDA product code DHN (Antinuclear Antibody, 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)