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FDA 510(k)

CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST

K-Number: K951754 · 1995-10-16

ApplicantHardy Diagnostics
Decision Date1995-10-16
Product CodeJSO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Hardy Diagnostics. It received FDA 510(k) clearance on 1995-10-16 under 510(k) number K951754. The device is classified under product code JSO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST?

CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST is a medical device that received FDA 510(k) clearance on 1995-10-16. The listed applicant is Hardy Diagnostics. The 510(k) number is K951754.

When did CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST receive FDA 510(k) clearance?

CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST received FDA 510(k) clearance on 1995-10-16, under 510(k) number K951754.

Who is the listed applicant for CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST?

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

What is the FDA product code for CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST?

The FDA product code for CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST is JSO.

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Related Devices (Code: JSO)

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.

K190553HardyCHROM CREHardy DiagnosticsK181092CHROMID CARBA agar (CARB)Biomerieux S.A.K171061MRSASelect IIBio-RadK162620Remel Spectra ESBLRemel, Inc.K160512HardyCHROM ESBLHardy DiagnosticsK162076chromID MRSAbioMerieux, Inc.

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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