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FDA 510(k)

BIO-MONITOR AMIKACIN

K-Number: K780949 · 1978-08-14

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

Device Summary

BIO-MONITOR AMIKACIN 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 K780949. The device is classified under product code KLP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-MONITOR AMIKACIN?

BIO-MONITOR AMIKACIN 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 K780949.

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

BIO-MONITOR AMIKACIN received FDA 510(k) clearance on 1978-08-14, under 510(k) number K780949.

Who is the listed applicant for BIO-MONITOR AMIKACIN?

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 AMIKACIN?

The FDA product code for BIO-MONITOR AMIKACIN is KLP.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 ACIDK780950BIO-MONITOR TOBRAMYCINK780951BIO-MONITOR GENTAMICINK772038KANAMYCIN RIAK772039BETA-HCG RIA

Related Devices (Code: KLP)

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.

K032279ONLINE TDM AMIKARoche Diagnostics Corp.K873426EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645Em Diagnostic Systems, Inc.K790899BACTECBd Becton Dickinson Vacutainer Systems Preanalytic

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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