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FDA 510(k)

BION MUMPS-G ANTIBODY TEST SYSTEM

K-Number: K926066 · 1993-06-15

ApplicantBion Ent., Ltd.
Decision Date1993-06-15
Product CodeCAR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BION MUMPS-G ANTIBODY TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bion Ent., Ltd.. It received FDA 510(k) clearance on 1993-06-15 under 510(k) number K926066. The device is classified under product code CAR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BION MUMPS-G ANTIBODY TEST SYSTEM?

BION MUMPS-G ANTIBODY TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1993-06-15. The listed applicant is Bion Ent., Ltd.. The 510(k) number is K926066.

When did BION MUMPS-G ANTIBODY TEST SYSTEM receive FDA 510(k) clearance?

BION MUMPS-G ANTIBODY TEST SYSTEM received FDA 510(k) clearance on 1993-06-15, under 510(k) number K926066.

Who is the listed applicant for BION MUMPS-G ANTIBODY TEST SYSTEM?

The FDA 510(k) record lists Bion Ent., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BION MUMPS-G ANTIBODY TEST SYSTEM?

The FDA product code for BION MUMPS-G ANTIBODY TEST SYSTEM is CAR.

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Other records listing Bion Ent., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K901054BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDEK894622VARICELLA ZOSTER VIRUSK894623RESPIRATORY SYNCYTIAL VIRUSK894624MUMPS VIRUSK894626EPSTEIN-BARR VIRUS-NUCLEAR ANTIGENK891785BION EBV-G (VCA) TEST SYSTEM

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Related Devices (Code: CAR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K920740EPISENSOR PLUSIndustrias Palex C/O Dma Med-Chem Corp.K915577IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICEImpra, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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