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FDA 510(k)

DRUGCHECK X MULTIDRUG SCREENING DEVICE

K-Number: K992748 · 1999-09-02

Decision Date1999-09-02
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DRUGCHECK X MULTIDRUG SCREENING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Syntron Bioresearch, Inc.. It received FDA 510(k) clearance on 1999-09-02 under 510(k) number K992748. 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 DRUGCHECK X MULTIDRUG SCREENING DEVICE?

DRUGCHECK X MULTIDRUG SCREENING DEVICE is a medical device that received FDA 510(k) clearance on 1999-09-02. The listed applicant is Syntron Bioresearch, Inc.. The 510(k) number is K992748.

When did DRUGCHECK X MULTIDRUG SCREENING DEVICE receive FDA 510(k) clearance?

DRUGCHECK X MULTIDRUG SCREENING DEVICE received FDA 510(k) clearance on 1999-09-02, under 510(k) number K992748.

Who is the listed applicant for DRUGCHECK X MULTIDRUG SCREENING DEVICE?

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

What is the FDA product code for DRUGCHECK X MULTIDRUG SCREENING DEVICE?

The FDA product code for DRUGCHECK X MULTIDRUG SCREENING DEVICE is DIO.

Related Clinical Trials

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.

Other records listing Syntron Bioresearch, 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.

View all 26 devices →

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.

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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