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FDA 510(k)

ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST

K-Number: K883940 · 1989-01-04

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1989-01-04
Product CodeLIQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1989-01-04 under 510(k) number K883940. The device is classified under product code LIQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST?

ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST is a medical device that received FDA 510(k) clearance on 1989-01-04. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K883940.

When did ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST receive FDA 510(k) clearance?

ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST received FDA 510(k) clearance on 1989-01-04, under 510(k) number K883940.

Who is the listed applicant for ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST?

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

What is the FDA product code for ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST?

The FDA product code for ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST is LIQ.

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Other records listing Ortho Diagnostic Systems, 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.

K951459ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATEK951632ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)K964754ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATEK963902QUANTITATIVE FIBRINOGEN ASSAYK950625ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)K950568ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)

View all 126 devices →

Related Devices (Code: LIQ)

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.

K990842SAS ROTA TESTSa Scientific, Inc.K972895VIDAS ROTAVIRUS (RTV) ASSAYBiomerieux Vitek, Inc.K971585IMMUNOCARD STAT! ROTAVIRUSMeridian Diagnostics, Inc.K964424ROTAVIRUS EIATrinity Biotech, Inc.K965092VIDAS ROTAVIRUS ASSAYBiomerieux Vitek, Inc.K951208ROTA-DAN RAPID ROTAVIRUS EIA KITEldan Technologies, Ltd.

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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