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FDA 510(k)

PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGEN

K-Number: K872695 · 1987-09-18

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

Device Summary

PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGEN 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 K872695. The device is classified under product code GQT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGEN?

PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGEN 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 K872695.

When did PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGEN receive FDA 510(k) clearance?

PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGEN received FDA 510(k) clearance on 1987-09-18, under 510(k) number K872695.

Who is the listed applicant for PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGEN?

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 PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGEN?

The FDA product code for PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGEN is GQT.

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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 ANTIGENK872701RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROLK872696PARAINFLUENZA-3-CF ANTIGEN AND CONTROL ANTIGENK872699MUMPS CF ANTIGEN AND CONTROL ANTIGEN

View all 9 devices →

Related Devices (Code: GQT)

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.

K872696PARAINFLUENZA-3-CF ANTIGEN AND CONTROL ANTIGENSita, Inc.K872697PARAINFLUENZA-I-CF ANTIGEN AND CONTROL ANTIGENSita, Inc.K780008GOAT ANTI-INFLUENZA ANTISERANortheast Biomedical Labs., 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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