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FDA 510(k)

PARAKIT

K-Number: K941110 · 1994-05-17

ApplicantHardy Diagnostics
Decision Date1994-05-17
Product CodeLKS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PARAKIT is the device name listed in this FDA 510(k) record. The listed applicant is Hardy Diagnostics. It received FDA 510(k) clearance on 1994-05-17 under 510(k) number K941110. The device is classified under product code LKS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARAKIT?

PARAKIT is a medical device that received FDA 510(k) clearance on 1994-05-17. The listed applicant is Hardy Diagnostics. The 510(k) number is K941110.

When did PARAKIT receive FDA 510(k) clearance?

PARAKIT received FDA 510(k) clearance on 1994-05-17, under 510(k) number K941110.

Who is the listed applicant for PARAKIT?

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 PARAKIT?

The FDA product code for PARAKIT is LKS.

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Other records listing Hardy Diagnostics as applicant

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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: LKS)

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.

K053257PARA-PRO FC50Alpha-Tec Systems, Inc.K021420PARACON II/FECAL CONCENTRATOR IIPara Scientific Co.K980077PARA-PAK SPINCONMeridian Diagnostics, Inc.K941129CON-KITMedical Chemical Corp.K935316PARASAFE(R) FIXATIVEScientific Device Laboratory, Inc.K933370STOOL TRANSPORT/PROCESSORSage Products, 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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