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FDA 510(k)

REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION

K-Number: K911954 · 1991-05-23

ApplicantBio-Rad
Decision Date1991-05-23
Product CodeDJR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1991-05-23 under 510(k) number K911954. The device is classified under product code DJR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION?

REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-05-23. The listed applicant is Bio-Rad. The 510(k) number is K911954.

When did REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION receive FDA 510(k) clearance?

REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION received FDA 510(k) clearance on 1991-05-23, under 510(k) number K911954.

Who is the listed applicant for REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION?

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(TM) DRUG PROFILING SYSTEM, MODIFICATION?

The FDA product code for REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION is DJR.

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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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