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FDA 510(k)

ORTHO RESPIRATORY SYNCYTIAL VIRUS-

K-Number: K841527 · 1984-08-12

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1984-08-12
Product CodeLKT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ORTHO RESPIRATORY SYNCYTIAL VIRUS- 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 1984-08-12 under 510(k) number K841527. 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 RESPIRATORY SYNCYTIAL VIRUS-?

ORTHO RESPIRATORY SYNCYTIAL VIRUS- is a medical device that received FDA 510(k) clearance on 1984-08-12. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K841527.

When did ORTHO RESPIRATORY SYNCYTIAL VIRUS- receive FDA 510(k) clearance?

ORTHO RESPIRATORY SYNCYTIAL VIRUS- received FDA 510(k) clearance on 1984-08-12, under 510(k) number K841527.

Who is the listed applicant for ORTHO RESPIRATORY SYNCYTIAL VIRUS-?

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 RESPIRATORY SYNCYTIAL VIRUS-?

The FDA product code for ORTHO RESPIRATORY SYNCYTIAL VIRUS- 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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