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FDA 510(k)

BIO-MONITOR GENTAMICIN

K-Number: K780951 · 1978-08-14

ApplicantMonitor Science Corp.
Decision Date1978-08-14
Product CodeDKD
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BIO-MONITOR GENTAMICIN is the device name listed in this FDA 510(k) record. The listed applicant is Monitor Science Corp.. It received FDA 510(k) clearance on 1978-08-14 under 510(k) number K780951. The device is classified under product code DKD. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-MONITOR GENTAMICIN?

BIO-MONITOR GENTAMICIN is a medical device that received FDA 510(k) clearance on 1978-08-14. The listed applicant is Monitor Science Corp.. The 510(k) number is K780951.

When did BIO-MONITOR GENTAMICIN receive FDA 510(k) clearance?

BIO-MONITOR GENTAMICIN received FDA 510(k) clearance on 1978-08-14, under 510(k) number K780951.

Who is the listed applicant for BIO-MONITOR GENTAMICIN?

The FDA 510(k) record lists Monitor Science Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO-MONITOR GENTAMICIN?

The FDA product code for BIO-MONITOR GENTAMICIN is DKD.

Related Clinical Trials

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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Other records listing Monitor Science Corp. 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.

K790580RIA KIT, PROSTATIC ACIDK780949BIO-MONITOR AMIKACINK780950BIO-MONITOR TOBRAMYCINK772038KANAMYCIN RIAK772039BETA-HCG RIA

Related Devices (Code: DKD)

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.

K760942GENTASAKBd Becton Dickinson Vacutainer Systems Preanalytic

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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