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FDA 510(k)

M. CAT BUTYRATE DISK

K-Number: K960996 · 1996-04-18

ApplicantHardy Diagnostics
Decision Date1996-04-18
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

M. CAT BUTYRATE DISK is the device name listed in this FDA 510(k) record. The listed applicant is Hardy Diagnostics. It received FDA 510(k) clearance on 1996-04-18 under 510(k) number K960996. The device is classified under product code JTO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M. CAT BUTYRATE DISK?

M. CAT BUTYRATE DISK is a medical device that received FDA 510(k) clearance on 1996-04-18. The listed applicant is Hardy Diagnostics. The 510(k) number is K960996.

When did M. CAT BUTYRATE DISK receive FDA 510(k) clearance?

M. CAT BUTYRATE DISK received FDA 510(k) clearance on 1996-04-18, under 510(k) number K960996.

Who is the listed applicant for M. CAT BUTYRATE DISK?

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 M. CAT BUTYRATE DISK?

The FDA product code for M. CAT BUTYRATE DISK is JTO.

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Other records listing Hardy Diagnostics 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.

K262113HardyDisk AST Tebipenem 10µg (TBP10)K260842HardyDisk AST Gepotidacin 10µg (GEP10)K253105HardyDisk AST Cefiderocol 30µg (FDC30)K250956HardyDisk AST Gepotidacin 10µg (GEP10)K250454HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)K233534Viral Transport Medium

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Related Devices (Code: JTO)

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.

K050352IN-VITRO DIAGNOSTIC VAGINITIS TEST KITAmeritek Research, LLCK970832PYR SWABRemel, Inc.K970834GRAM SWABRemel, Inc.K970833INDOLE SWABRemel, Inc.K970009LYFO(TM) DIFFERENTIAL DISK-BACITRACINMicrobiologics, Inc.K962966IDS RAPID CB PLUS SYSTEMInnovative Diagnostic Systems, 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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