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FDA 510(k)

GENTAMICIN 500 UG/ML TO BE INCLUDED IN JUSTONE(TM)

K-Number: K912613 · 1991-08-22

ApplicantSensititre Microbiology A Div. of Radiometer
Decision Date1991-08-22
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GENTAMICIN 500 UG/ML TO BE INCLUDED IN JUSTONE(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Sensititre Microbiology A Div. of Radiometer. It received FDA 510(k) clearance on 1991-08-22 under 510(k) number K912613. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENTAMICIN 500 UG/ML TO BE INCLUDED IN JUSTONE(TM)?

GENTAMICIN 500 UG/ML TO BE INCLUDED IN JUSTONE(TM) is a medical device that received FDA 510(k) clearance on 1991-08-22. The listed applicant is Sensititre Microbiology A Div. of Radiometer. The 510(k) number is K912613.

When did GENTAMICIN 500 UG/ML TO BE INCLUDED IN JUSTONE(TM) receive FDA 510(k) clearance?

GENTAMICIN 500 UG/ML TO BE INCLUDED IN JUSTONE(TM) received FDA 510(k) clearance on 1991-08-22, under 510(k) number K912613.

Who is the listed applicant for GENTAMICIN 500 UG/ML TO BE INCLUDED IN JUSTONE(TM)?

The FDA 510(k) record lists Sensititre Microbiology A Div. of Radiometer as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENTAMICIN 500 UG/ML TO BE INCLUDED IN JUSTONE(TM)?

The FDA product code for GENTAMICIN 500 UG/ML TO BE INCLUDED IN JUSTONE(TM) is JWY.

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 Sensititre Microbiology A Div. of Radiometer 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.

K912778HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATEK912846JUSTONE(TM)

Related Devices (Code: JWY)

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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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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