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FDA 510(k)

REDI-TEST COCAINE

K-Number: K991110 · 1999-07-26

ApplicantRedwood Biotech, Inc.
Decision Date1999-07-26
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

REDI-TEST COCAINE is the device name listed in this FDA 510(k) record. The listed applicant is Redwood Biotech, Inc.. It received FDA 510(k) clearance on 1999-07-26 under 510(k) number K991110. 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 REDI-TEST COCAINE?

REDI-TEST COCAINE is a medical device that received FDA 510(k) clearance on 1999-07-26. The listed applicant is Redwood Biotech, Inc.. The 510(k) number is K991110.

When did REDI-TEST COCAINE receive FDA 510(k) clearance?

REDI-TEST COCAINE received FDA 510(k) clearance on 1999-07-26, under 510(k) number K991110.

Who is the listed applicant for REDI-TEST COCAINE?

The FDA 510(k) record lists Redwood Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REDI-TEST COCAINE?

The FDA product code for REDI-TEST COCAINE is DIO.

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Other records listing Redwood Biotech, Inc. 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.

K000979REDI-SCREENK993100REDI-SCREENK991698REDI-TEST PCPK991504REDI-TEST METHAMPHETAMINEK990870REDI-TEST THC

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 CorporationK191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DXK181499DRI Cocaine Metabolite AssayMicrogenics CorporationK170293Emit 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.

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