FDA 510(k)

RADS

K-Number: K011054 · 2001-07-30

Decision Date2001-07-30

Product CodeDIO

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

RADS is the device name listed in this FDA 510(k) record. The listed applicant is Chason Healthcare, LLC. It received FDA 510(k) clearance on 2001-07-30 under 510(k) number K011054. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADS?

RADS is a medical device that received FDA 510(k) clearance on 2001-07-30. The listed applicant is Chason Healthcare, LLC. The 510(k) number is K011054.

When did RADS receive FDA 510(k) clearance?

RADS received FDA 510(k) clearance on 2001-07-30, under 510(k) number K011054.

Who is the listed applicant for RADS?

The FDA 510(k) record lists Chason Healthcare, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RADS?

The FDA product code for RADS is DIO.

Related Devices (Code: DIO)

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.

K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test SystemCarolina Liquid Chemistries Corp.K211973DRI Cocaine Metabolite AssayMicrogenics Corporation K191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DX K181499DRI Cocaine Metabolite AssayMicrogenics Corporation K170293Emit II Plus Cocaine Metabolite AssaySiemens Healthcare Diagnostics, Inc.K163570Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)Carolina Liquid Chemistries Corporation

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.