Immco Diagnostics 2100X

by Immco Diagnostics, Inc.

Immco Diagnostics 2100X is a Class II device made by Immco Diagnostics, Inc., cleared under FDA 510(k) K982898 on 30 Nov 1998 (5 earlier submissions) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00845714003479), 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

+5 more

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00845714003479 UDI-DI	Date23 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK982898	Date30 Nov 1998Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK891098	Date22 Mar 1989Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK891099	Date22 Mar 1989Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK884400	Date4 Nov 1988Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK883883	Date27 Oct 1988Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK883915	Date19 Oct 1988Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00845714003479
FDA 510(k) database 510(k) number K982898
FDA 510(k) database 510(k) number K891098
FDA 510(k) database 510(k) number K891099
FDA 510(k) database 510(k) number K884400
FDA 510(k) database 510(k) number K883883
FDA 510(k) database 510(k) number K883915

Across registries

2 registries list this device

FDA 510(k) K982898 decided 30 Nov 1998 Active· +5 more in the status table
FDA GUDID UDI-DI 00845714003479 listed 23 Sep 2016 Listed

Timeline

7 dated events

19 Oct 1988 Cleared FDA 510(k) K883915
27 Oct 1988 Cleared FDA 510(k) K883883
4 Nov 1988 Cleared FDA 510(k) K884400
22 Mar 1989 Cleared FDA 510(k) K891098
22 Mar 1989 Cleared FDA 510(k) K891099
30 Nov 1998 Cleared FDA 510(k) K982898
23 Sep 2016 Listed FDA GUDID 00845714003479

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Immco Diagnostics
Generic name: Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
Model / Ref / Catalog: 2100X

Primary DI / UDI-DI: 00845714003479
510(k) Number: K883883
K883915
K884400
K891098
K891099
K982898
FDA product code: MOB, DHN, DBL, LKJ
GMDN term: Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD

Device class: Class II
Regulation number: 866.5660, 866.5100
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Lot / batch number
Expiration date
Manufacturing date

Other properties (11, all answered No)