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FDA 510(k)

MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT

K-Number: K861379 · 1986-07-16

ApplicantSerono Diagnostics, Inc.
Decision Date1986-07-16
Product CodeLKT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Serono Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-07-16 under 510(k) number K861379. 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 MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT?

MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT is a medical device that received FDA 510(k) clearance on 1986-07-16. The listed applicant is Serono Diagnostics, Inc.. The 510(k) number is K861379.

When did MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT receive FDA 510(k) clearance?

MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT received FDA 510(k) clearance on 1986-07-16, under 510(k) number K861379.

Who is the listed applicant for MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT?

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

What is the FDA product code for MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT?

The FDA product code for MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT is LKT.

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Other records listing Serono Diagnostics, 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.

K953598SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERSK942051SR1 DHEA-S ENZYME IMMUNOASSAYK883085T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHASK882340LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHAK880388T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASEK874866T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE

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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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