Centria System 2 Automated Method/Ria

FDA 510(k) K801037 · Union Carbide Corp.

Substantially Equivalent

510(k) numberK801037

Submission

Device name
Centria System 2 Automated Method/Ria
Applicant
Union Carbide Corp.
Walker, MI, US
Received
May 2, 1980
Decision date
May 28, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LCI – Automated Radioimmunoassay Systems, For Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2050
Specialty
Clinical Chemistry

Other 510(k)s with product code LCI

510(k)DeviceApplicantDecision
K98361725-HYDROXYVITAMIN D 125I Ria KitLCI · Special DiaSorin, Inc.11/16/1998SE
K780886System 6000 Automated Ria AnalyzerLCI · Traditional Beckman Instruments, Inc.09/01/1978SE

More from Beckman Instruments, Inc.

510(k)DeviceDecision
K830337Mark III Oxygen Walker Sys-Low PressBYJ · Traditional 03/17/1983SE
K820836Mark III Oxygen Walker SystemBYJ · Traditional 04/15/1982SE
K820535Laser Gas MixturesEWG · Traditional 03/31/1982SE
K812536Linde Mark IIBYJ · Traditional 09/23/1981SE
K810732Linde Mark II Oxygen Reserv. Type OR-4BYJ · Traditional 03/27/1981SE
K810596Centrifi Chem System 400 AnalyzerJJE · Traditional 03/17/1981SE
K810129Centrifichem System 500JJE · Traditional 02/02/1981SE
K803216Centrifichem Ast/Sgot Optimized ReagentCIT · Traditional 01/09/1981SE
K802741Centrifichem Comb. Serum-Based Calib.JIX · Traditional 12/10/1980SE
K802520Centrifichem Pipettor Accuracy Calib.JQW · Traditional 11/12/1980SE

Questions and answers

When was Centria System 2 Automated Method/Ria cleared by the FDA?

Centria System 2 Automated Method/Ria (K801037) received a 510(k) decision of Substantially Equivalent on May 28, 1980, 26 days after the submission was received.

What is the product code of K801037?

The FDA product code is LCI – Automated Radioimmunoassay Systems, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2050.