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FDA 510(k)

RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL

K-Number: K872701 · 1987-09-18

ApplicantSita, Inc.
Decision Date1987-09-18
Product CodeLKT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Sita, Inc.. It received FDA 510(k) clearance on 1987-09-18 under 510(k) number K872701. 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 RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL?

RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL is a medical device that received FDA 510(k) clearance on 1987-09-18. The listed applicant is Sita, Inc.. The 510(k) number is K872701.

When did RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL receive FDA 510(k) clearance?

RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL received FDA 510(k) clearance on 1987-09-18, under 510(k) number K872701.

Who is the listed applicant for RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL?

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

What is the FDA product code for RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL?

The FDA product code for RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL is LKT.

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Other records listing Sita, 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.

K872700YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGENK872694YNFLUENZA A VIRUS CF ANTIGEN AND CONTROL ANTIGENK872693INFLUENZA B VIRUS CF ANTIGEN AND CONTROL ANTIGENK872695PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGENK872696PARAINFLUENZA-3-CF ANTIGEN AND CONTROL ANTIGENK872699MUMPS CF ANTIGEN AND CONTROL ANTIGEN

View all 9 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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