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Immco Diagnostics 2314

by Immco Diagnostics, Inc.

Immco Diagnostics 2314 is a Class II device made by Immco Diagnostics, Inc., cleared under FDA 510(k) K113020 on 25 Oct 2012 and listed in FDA GUDID since 15 Nov 2016 (UDI-DI 00845714002823), 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) K113020

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 Number00845714002823 UDI-DI Date15 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK113020 Date25 Oct 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K113020 decided 25 Oct 2012 Active
  • FDA GUDID UDI-DI 00845714002823 listed 15 Nov 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K113020
  2. Listed FDA GUDID 00845714002823

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  • Withdrawn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
Buffered wash solution IVD, manual
Model / Ref / Catalog
2314
Primary DI / UDI-DI
00845714002823
510(k) Number
FDA product code
MID
GMDN term
Buffered wash solution IVD, manual
Device class
Class II
Regulation number
866.5660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Buffered wash solution IVD, manual

Similar devices

Other devices filed under FDA product code MID (System, Test, Anticardiolipin Immunological).

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)