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FDA 510(k)

ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS

K-Number: K831924 · 1983-08-11

ApplicantElectro-Nucleonics Laboratories, Inc.
Decision Date1983-08-11
Product CodeLKT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Nucleonics Laboratories, Inc.. It received FDA 510(k) clearance on 1983-08-11 under 510(k) number K831924. 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 ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS?

ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS is a medical device that received FDA 510(k) clearance on 1983-08-11. The listed applicant is Electro-Nucleonics Laboratories, Inc.. The 510(k) number is K831924.

When did ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS receive FDA 510(k) clearance?

ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS received FDA 510(k) clearance on 1983-08-11, under 510(k) number K831924.

Who is the listed applicant for ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS?

The FDA 510(k) record lists Electro-Nucleonics Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS?

The FDA product code for ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS is LKT.

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Other records listing Electro-Nucleonics Laboratories, 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.

K873925VIRGO(TM) MEASLES IGG ELISAK873617GEMSTAR II SYSTEMK873416MULTI-ACCESS REAGENT DISPENSERK873358GEMENI URIC ACID U.V.K873088VIRGO(TM) RUBELLA IGG ELISAK871905TOXOPLASMA GONDII IGG ELISA

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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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