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FDA 510(k)

REMEDI HS DRUG PROFILING SYSTEM

K-Number: K941596 · 1995-03-27

ApplicantBio-Rad
Decision Date1995-03-27
Product CodeDNI
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

REMEDI HS DRUG PROFILING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1995-03-27 under 510(k) number K941596. The device is classified under product code DNI. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REMEDI HS DRUG PROFILING SYSTEM?

REMEDI HS DRUG PROFILING SYSTEM is a medical device that received FDA 510(k) clearance on 1995-03-27. The listed applicant is Bio-Rad. The 510(k) number is K941596.

When did REMEDI HS DRUG PROFILING SYSTEM receive FDA 510(k) clearance?

REMEDI HS DRUG PROFILING SYSTEM received FDA 510(k) clearance on 1995-03-27, under 510(k) number K941596.

Who is the listed applicant for REMEDI HS DRUG PROFILING SYSTEM?

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

What is the FDA product code for REMEDI HS DRUG PROFILING SYSTEM?

The FDA product code for REMEDI HS DRUG PROFILING SYSTEM is DNI.

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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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