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FDA 510(k)

MACRO-VUE TEST, GENTAMICIN

K-Number: K781674 · 1978-11-15

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1978-11-15
Product CodeDJB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MACRO-VUE TEST, GENTAMICIN is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1978-11-15 under 510(k) number K781674. 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 MACRO-VUE TEST, GENTAMICIN?

MACRO-VUE TEST, GENTAMICIN is a medical device that received FDA 510(k) clearance on 1978-11-15. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K781674.

When did MACRO-VUE TEST, GENTAMICIN receive FDA 510(k) clearance?

MACRO-VUE TEST, GENTAMICIN received FDA 510(k) clearance on 1978-11-15, under 510(k) number K781674.

Who is the listed applicant for MACRO-VUE TEST, GENTAMICIN?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MACRO-VUE TEST, GENTAMICIN?

The FDA product code for MACRO-VUE TEST, GENTAMICIN 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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