Eia Rubella-G

FDA 510(k) K802339 · Beckman Instruments, Inc.

Substantially Equivalent

510(k) numberK802339

Submission

Device name
Eia Rubella-G
Applicant
Beckman Instruments, Inc.
Mchenry, IL, US
Received
September 26, 1980
Decision date
December 18, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GOL – Antigen, Ha (Including Ha Control), Rubella
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3510
Specialty
Microbiology

Other 510(k)s with product code GOL

510(k)DeviceApplicantDecision
K841174Rubella Antibody FluoroimmunoassayGOL · Traditional Intl. Diagnostic Technology06/07/1984SE
K834032Rubaquick Diagnostic KitGOL · Traditional Abbott Laboratories04/17/1984SE
K810309Rubella Antibodies Test ReagentsGOL · Traditional Calbiochem-Behring Corp.03/11/1981SE
K802508Rubelisa Igm Test KitGOL · Traditional M.A. Bioproducts12/18/1980SE
K802102Rubella Elisa Reagents Rubella Igg AntiGOL · Traditional Calbiochem-Behring Corp.12/18/1980SE
K801667Gamma COAT(125 I) Rubella AntibodyGOL · Traditional Clinical Assays, Inc.10/23/1980SE
K801098Enzyme-Immunoassay (Rubella Antibodies)GOL · Traditional Flow Laboratories, Inc.09/16/1980SE
K801507Antigen Control CellsGOL · Traditional Ortho Diagnostics, Inc.08/20/1980SE
K800789Rubella Bio-Bead Titration KitGOL · Traditional Litton Bionetics06/30/1980SE
K800797Macro-Vue Rubella Card TestGOL · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic06/20/1980SE

More from Bd Becton Dickinson Vacutainer Systems Preanalytic

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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
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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 Eia Rubella-G cleared by the FDA?

Eia Rubella-G (K802339) received a 510(k) decision of Substantially Equivalent on December 18, 1980, 83 days after the submission was received.

What is the product code of K802339?

The FDA product code is GOL – Antigen, Ha (Including Ha Control), Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.