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FDA 510(k)

COXSACKIE VIRUS B1-B6 CF ANTIGENS

K-Number: K921618 · 1992-06-29

ApplicantVirion (U.S.), Inc.
Decision Date1992-06-29
Product CodeGNG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COXSACKIE VIRUS B1-B6 CF ANTIGENS is the device name listed in this FDA 510(k) record. The listed applicant is Virion (U.S.), Inc.. It received FDA 510(k) clearance on 1992-06-29 under 510(k) number K921618. The device is classified under product code GNG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COXSACKIE VIRUS B1-B6 CF ANTIGENS?

COXSACKIE VIRUS B1-B6 CF ANTIGENS is a medical device that received FDA 510(k) clearance on 1992-06-29. The listed applicant is Virion (U.S.), Inc.. The 510(k) number is K921618.

When did COXSACKIE VIRUS B1-B6 CF ANTIGENS receive FDA 510(k) clearance?

COXSACKIE VIRUS B1-B6 CF ANTIGENS received FDA 510(k) clearance on 1992-06-29, under 510(k) number K921618.

Who is the listed applicant for COXSACKIE VIRUS B1-B6 CF ANTIGENS?

The FDA 510(k) record lists Virion (U.S.), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COXSACKIE VIRUS B1-B6 CF ANTIGENS?

The FDA product code for COXSACKIE VIRUS B1-B6 CF ANTIGENS is GNG.

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 Virion (U.S.), Inc. 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.

K933251EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TESTK905306MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGENK905385P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGENK864981TOXOPLASMA GONDII

Related Devices (Code: GNG)

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.

K850003COXSACKIE B SERIES CF ANTIGENSHillcrest Biologicals

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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