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FDA 510(k)

PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR

K-Number: K802935 · 1980-12-31

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

Device Summary

PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR 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 K802935. The device is classified under product code GQS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR?

PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR 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 K802935.

When did PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR receive FDA 510(k) clearance?

PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR received FDA 510(k) clearance on 1980-12-31, under 510(k) number K802935.

Who is the listed applicant for PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR?

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 PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR?

The FDA product code for PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR is GQS.

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Other records listing Orion Diagnostica, Inc. as applicant

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K942286DIARLEX ROTA-ADENOK914892SALIVA-STIMK904655PYLORISETK884147IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN MK884074IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN GK884075IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN

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Related Devices (Code: GQS)

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.

K093415D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KITDiagnostic Hybrids, Inc.K943557IMAGENDako Diagnostics , Ltd.K905385P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGENVirion (U.S.), Inc.K884194PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECTBaxter Diagnostics, Inc.K884193PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECTBaxter Diagnostics, Inc.K871228ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2Microscan Div. Baxter Healthcare Corp.

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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