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FDA 510(k)

VARICELLA-ZOSTER ANTIGENS & CONTROLS

K-Number: K802938 · 1980-12-31

ApplicantOrion Diagnostica, Inc.
Decision Date1980-12-31
Product CodeGQW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VARICELLA-ZOSTER ANTIGENS & CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Orion Diagnostica, Inc.. It received FDA 510(k) clearance on 1980-12-31 under 510(k) number K802938. The device is classified under product code GQW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARICELLA-ZOSTER ANTIGENS & CONTROLS?

VARICELLA-ZOSTER ANTIGENS & CONTROLS is a medical device that received FDA 510(k) clearance on 1980-12-31. The listed applicant is Orion Diagnostica, Inc.. The 510(k) number is K802938.

When did VARICELLA-ZOSTER ANTIGENS & CONTROLS receive FDA 510(k) clearance?

VARICELLA-ZOSTER ANTIGENS & CONTROLS received FDA 510(k) clearance on 1980-12-31, under 510(k) number K802938.

Who is the listed applicant for VARICELLA-ZOSTER ANTIGENS & CONTROLS?

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

What is the FDA product code for VARICELLA-ZOSTER ANTIGENS & CONTROLS?

The FDA product code for VARICELLA-ZOSTER ANTIGENS & CONTROLS is GQW.

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Other records listing Orion Diagnostica, Inc. as applicant

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Related Devices (Code: GQW)

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.

K070206DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000Diagnostic Hybrids, Inc.K990141LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295Light DiagnosticsK964872VZV ANTIGEN CONTROL SLIDESViral Antigens, Inc.K942743VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENTViro Research, Inc.K912239VZVSCAN(TM) LATEX AGGUTINATION TESTBd Becton Dickinson Vacutainer Systems PreanalyticK903882VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGGViral Antigens, 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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