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FDA 510(k)

Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard

K-Number: K153050 · 2016-04-26

ApplicantCo-Innovation Biotech Co., Ltd.
Decision Date2016-04-26
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard is the device name listed in this FDA 510(k) record. The listed applicant is Co-Innovation Biotech Co., Ltd.. It received FDA 510(k) clearance on 2016-04-26 under 510(k) number K153050. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard?

Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard is a medical device that received FDA 510(k) clearance on 2016-04-26. The listed applicant is Co-Innovation Biotech Co., Ltd.. The 510(k) number is K153050.

When did Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard receive FDA 510(k) clearance?

Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard received FDA 510(k) clearance on 2016-04-26, under 510(k) number K153050.

Who is the listed applicant for Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard?

The FDA 510(k) record lists Co-Innovation Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard?

The FDA product code for Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard is DJG.

Other records listing Co-Innovation Biotech Co., Ltd. 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.

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Related Devices (Code: DJG)

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.

K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories LimitedK253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc.K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis CorporationK251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)Healgen Scientific,, LLCK251634LZI Fentanyl III Enzyme ImmunoassayLin-Zhi International, Inc.

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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