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FDA 510(k)

MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN

K-Number: K905306 · 1991-06-17

ApplicantVirion (U.S.), Inc.
Decision Date1991-06-17
Product CodeGRC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN 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 1991-06-17 under 510(k) number K905306. The device is classified under product code GRC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN?

MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN is a medical device that received FDA 510(k) clearance on 1991-06-17. The listed applicant is Virion (U.S.), Inc.. The 510(k) number is K905306.

When did MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN receive FDA 510(k) clearance?

MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN received FDA 510(k) clearance on 1991-06-17, under 510(k) number K905306.

Who is the listed applicant for MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN?

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 MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN?

The FDA product code for MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN is GRC.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 TESTK921618COXSACKIE VIRUS B1-B6 CF ANTIGENSK905385P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGENK864981TOXOPLASMA GONDII

Related Devices (Code: GRC)

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.

K832873MUMPS COMPLEMENT FIXATION & HEMAGGLUHazleton Dutchland, Inc.K802933MUMPS S & V ANTIGENS & CONTROLSOrion Diagnostica, 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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