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FDA 510(k)

MUMPS VIRUS

K-Number: K894624 · 1989-10-16

ApplicantBion Ent., Ltd.
Decision Date1989-10-16
Product CodeGRA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MUMPS VIRUS 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 1989-10-16 under 510(k) number K894624. The device is classified under product code GRA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MUMPS VIRUS?

MUMPS VIRUS is a medical device that received FDA 510(k) clearance on 1989-10-16. The listed applicant is Bion Ent., Ltd.. The 510(k) number is K894624.

When did MUMPS VIRUS receive FDA 510(k) clearance?

MUMPS VIRUS received FDA 510(k) clearance on 1989-10-16, under 510(k) number K894624.

Who is the listed applicant for MUMPS VIRUS?

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 MUMPS VIRUS?

The FDA product code for MUMPS VIRUS is GRA.

Related Clinical Trials

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.

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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.

K926066BION MUMPS-G ANTIBODY TEST SYSTEMK901054BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDEK894622VARICELLA ZOSTER VIRUSK894623RESPIRATORY SYNCYTIAL VIRUSK894626EPSTEIN-BARR VIRUS-NUCLEAR ANTIGENK891785BION EBV-G (VCA) TEST SYSTEM

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Related Devices (Code: GRA)

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.

K822826ANTIBODY TO MUMPS VIRUS IFA TESTElectro-Nucleonics Laboratories, Inc.K770216VIRAL ANTISERA, FLUORESCEIN LABELEDFlow Laboratories, 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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