Bion Mumps-G Antibody Test System

FDA 510(k) K926066 · Bion Ent., Ltd.

Substantially Equivalent

510(k) numberK926066

Submission

Device name
Bion Mumps-G Antibody Test System
Applicant
Bion Ent., Ltd.
Park Ridge, IL, US
Received
December 1, 1992
Decision date
June 15, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CAR – Monitor, Spinal-Fluid Pressure, Electrically Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 880.2460
Specialty
General Hospital

Other 510(k)s with product code CAR

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K920740Episensor PlusCAR · Traditional Industrias Palex C/O Dma Med-Chem Corp.03/07/1994SE
K915577Impraflo Postoperative Autotransfusion DeviceCAR · Traditional Impra, Inc.03/11/1992SE

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Questions and answers

When was Bion Mumps-G Antibody Test System cleared by the FDA?

Bion Mumps-G Antibody Test System (K926066) received a 510(k) decision of Substantially Equivalent on June 15, 1993, 196 days after the submission was received.

What is the product code of K926066?

The FDA product code is CAR – Monitor, Spinal-Fluid Pressure, Electrically Powered, a Class II (moderate risk) device regulated under 21 CFR 880.2460.