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FDA 510(k)

FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY

K-Number: K791547 · 1979-10-12

ApplicantBio-Rad
Decision Date1979-10-12
Product CodeDJB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1979-10-12 under 510(k) number K791547. The device is classified under product code DJB. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY?

FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1979-10-12. The listed applicant is Bio-Rad. The 510(k) number is K791547.

When did FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY receive FDA 510(k) clearance?

FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY received FDA 510(k) clearance on 1979-10-12, under 510(k) number K791547.

Who is the listed applicant for FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY?

The FDA 510(k) record lists Bio-Rad as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY?

The FDA product code for FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY is DJB.

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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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