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FDA 510(k)

QUANTIMUNE GENTAMICIN RIA GENTAMICIN

K-Number: K791770 · 1979-10-17

ApplicantBio-Rad
Decision Date1979-10-17
Product CodeDJB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QUANTIMUNE GENTAMICIN RIA GENTAMICIN is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1979-10-17 under 510(k) number K791770. 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 QUANTIMUNE GENTAMICIN RIA GENTAMICIN?

QUANTIMUNE GENTAMICIN RIA GENTAMICIN is a medical device that received FDA 510(k) clearance on 1979-10-17. The listed applicant is Bio-Rad. The 510(k) number is K791770.

When did QUANTIMUNE GENTAMICIN RIA GENTAMICIN receive FDA 510(k) clearance?

QUANTIMUNE GENTAMICIN RIA GENTAMICIN received FDA 510(k) clearance on 1979-10-17, under 510(k) number K791770.

Who is the listed applicant for QUANTIMUNE GENTAMICIN RIA GENTAMICIN?

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 QUANTIMUNE GENTAMICIN RIA GENTAMICIN?

The FDA product code for QUANTIMUNE GENTAMICIN RIA GENTAMICIN is DJB.

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Other records listing Bio-Rad 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.

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Related Devices (Code: DJB)

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.

K832792AMES TDA SISOMICIN TEST-CONTROL SERUMMiles Laboratories, Inc.K831210GENTAMICIN TEST PACK-ACAE.I. Dupont DE Nemours & Co., Inc.K821669AMES TDA GENTAMICIN TESTMiles Laboratories, Inc.K812394MRI GENTAMICIN RIA KITMicroanalytic Research, Inc.K811844COAT-A-COUNT GENTAMICIN RIA KITDiagnostic Products Corp.K800537GAMMA STICK GENTAMICIN RIA KITAlpha Gamma Laboratory

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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