Diamedix 720-270

by Diamedix Corp.

Diamedix 720-270 is a Class II device made by Diamedix Corp., cleared under FDA 510(k) K970238 on 8 Apr 1997 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00817273020105), active as of 22 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 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00817273020105 UDI-DI	Date20 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK970238	Date8 Apr 1997Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00817273020105
FDA 510(k) database 510(k) number K970238

Across registries

2 registries list this device

FDA 510(k) K970238 decided 8 Apr 1997 Active
FDA GUDID UDI-DI 00817273020105 listed 20 Sep 2016 Listed

Timeline

2 dated events

8 Apr 1997 Cleared FDA 510(k) K970238
20 Sep 2016 Listed FDA GUDID 00817273020105

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Diamedix
Generic name: Sm/RNP antibody IVD, control
Model / reference: 720-270
Description: "720-270 anti-SM/RNP Test Kit"

Primary DI / UDI-DI: 00817273020105
510(k) Number: K970238
FDA product code: LLL
GMDN term: Sm/RNP antibody IVD, control

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

Other devices from Diamedix Corp.

Diamedix 720-380

Class II
Diamedix 789-008

Class I
Diamedix 720-250

Class II
Diamedix 720-540

Class I

See all devices from Diamedix Corp. →

Properties

Convenience kit
Lot / batch number

Other properties (13, all answered No)