Immco Diagnostics 2302

by Immco Diagnostics, Inc.

Immco Diagnostics 2302 is a Class II device made by Immco Diagnostics, Inc., cleared under FDA 510(k) K060157 on 25 May 2006 (9 earlier submissions) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00845714004315), 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

+9 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	Number00845714004315 UDI-DI	Date23 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK060157	Date25 May 2006Decided	StatusActive
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	NumberK913360	Date26 Sep 1994Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK912551	Date9 Jun 1993Decided	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	NumberK883949	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 00845714004315
FDA 510(k) database 510(k) number K060157
FDA 510(k) database 510(k) number K982898
FDA 510(k) database 510(k) number K913360
FDA 510(k) database 510(k) number K912551
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 K883949
FDA 510(k) database 510(k) number K883915

Across registries

2 registries list this device

FDA 510(k) K060157 decided 25 May 2006 Active· +9 more in the status table
FDA GUDID UDI-DI 00845714004315 listed 23 Sep 2016 Listed

Timeline

11 dated events

27 Oct 1988 Cleared FDA 510(k) K883883
27 Oct 1988 Cleared FDA 510(k) K883949
4 Nov 1988 Cleared FDA 510(k) K884400
22 Mar 1989 Cleared FDA 510(k) K891098
22 Mar 1989 Cleared FDA 510(k) K891099
9 Jun 1993 Cleared FDA 510(k) K912551
26 Sep 1994 Cleared FDA 510(k) K913360
30 Nov 1998 Cleared FDA 510(k) K982898
25 May 2006 Cleared FDA 510(k) K060157
23 Sep 2016 Listed FDA GUDID 00845714004315

1 earlier event are in the sections above.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Immco Diagnostics
Generic name: Buffered sample diluent IVD
Model / Ref / Catalog: 2302

Primary DI / UDI-DI: 00845714004315
510(k) Number: K060157
K883883
K883915
K883949
K884400
K891098
K891099
K912551
K913360
K982898
FDA product code: DBL, LKJ, MOB, DHN
GMDN term: Buffered sample diluent IVD

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

Similar devices in this category

Other devices filed under Buffered sample diluent IVD.

Other devices from Immco Diagnostics, Inc.

Immco Diagnostics 5162

Class II
Immco Diagnostics, Inc. 6101M-50

Class II
Immco Diagnostics 2302-60

Class II
Immco Diagnostics 2210

Class II

See all devices from Immco Diagnostics, Inc. →

Properties

Prescription use
Lot / batch number
Expiration date
Manufacturing date

Other properties (11, all answered No)