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FDA 510(k)

ORTHO* RSV ANTIGEN ELISA TEST SYS

K-Number: K842047 · 1984-10-05

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1984-10-05
Product CodeLKT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ORTHO* RSV ANTIGEN ELISA TEST SYS 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 1984-10-05 under 510(k) number K842047. The device is classified under product code LKT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO* RSV ANTIGEN ELISA TEST SYS?

ORTHO* RSV ANTIGEN ELISA TEST SYS is a medical device that received FDA 510(k) clearance on 1984-10-05. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K842047.

When did ORTHO* RSV ANTIGEN ELISA TEST SYS receive FDA 510(k) clearance?

ORTHO* RSV ANTIGEN ELISA TEST SYS received FDA 510(k) clearance on 1984-10-05, under 510(k) number K842047.

Who is the listed applicant for ORTHO* RSV ANTIGEN ELISA TEST SYS?

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* RSV ANTIGEN ELISA TEST SYS?

The FDA product code for ORTHO* RSV ANTIGEN ELISA TEST SYS is LKT.

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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: LKT)

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.

K081928D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KITDiagnostic Hybrids, Inc.K983336PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1Diagnostic Products Corp.K943317PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)Diagnostic Products Corp.K942173RSV ANTIGEN TESTNeogenexK912842RSV-MAB TESTGull Laboratories, Inc.K912838BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNOBaxter Diagnostics, 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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