System 6000 Automated Ria Analyzer

FDA 510(k) K780886 · Beckman Instruments, Inc.

Substantially Equivalent

510(k) numberK780886

Submission

Device name
System 6000 Automated Ria Analyzer
Applicant
Beckman Instruments, Inc.
Mchenry, IL, US
Received
May 26, 1978
Decision date
September 1, 1978
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
K801037Centria System 2 Automated Method/RiaLCI · Traditional Union Carbide Corp.05/28/1980SE

More from Union Carbide Corp.

510(k)DeviceDecision
K973448Access Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465…LGD · Traditional 09/17/1998SE
K982250Access Free T4 Reagents on the Access Immunoassay AnalyzerCEC · Traditional 07/14/1998SE
K981403Immage Immunochemistry System Valproic Acid (Vpa) ReagentDKB · Traditional 05/08/1998SE
K981354Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211LOJ · Traditional 05/01/1998SE
K980173Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505JHI · Traditional 03/18/1998SE
K974816Access(R) Psa Reagents on the Access(R) Immunoassay Analyzer 33220, 33225, 33229LTJ · Traditional 02/20/1998SE
K974564Immage Immunochemistry System ALPHA-2-MACROGLOBULIN ReagentDEB · Traditional 02/17/1998SE
K974110Immage Immunochemistry System Antithrombin III (AT3) ReagentJBQ · Traditional 12/24/1997SE
K974452Vigil Lipid ControlJJY · Traditional 12/17/1997SE
K973932Beckman Calibrator 2 (CAL2)JIX · Traditional 12/15/1997SE

Questions and answers

When was System 6000 Automated Ria Analyzer cleared by the FDA?

System 6000 Automated Ria Analyzer (K780886) received a 510(k) decision of Substantially Equivalent on September 1, 1978, 98 days after the submission was received.

What is the product code of K780886?

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