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FDA 510(k)

KIT, RIA, GENTAMICIN SULF.

K-Number: K760068 · 1976-07-20

ApplicantNew England Nuclear
Decision Date1976-07-20
Product CodeDJB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

KIT, RIA, GENTAMICIN SULF. is the device name listed in this FDA 510(k) record. The listed applicant is New England Nuclear. It received FDA 510(k) clearance on 1976-07-20 under 510(k) number K760068. 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 KIT, RIA, GENTAMICIN SULF.?

KIT, RIA, GENTAMICIN SULF. is a medical device that received FDA 510(k) clearance on 1976-07-20. The listed applicant is New England Nuclear. The 510(k) number is K760068.

When did KIT, RIA, GENTAMICIN SULF. receive FDA 510(k) clearance?

KIT, RIA, GENTAMICIN SULF. received FDA 510(k) clearance on 1976-07-20, under 510(k) number K760068.

Who is the listed applicant for KIT, RIA, GENTAMICIN SULF.?

The FDA 510(k) record lists New England Nuclear as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KIT, RIA, GENTAMICIN SULF.?

The FDA product code for KIT, RIA, GENTAMICIN SULF. is DJB.

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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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