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FDA 510(k)

SPEC(TM) EXTRACTION CARTRIDGE

K-Number: K901694 · 1990-06-01

ApplicantToxi-Lab, Inc.
Decision Date1990-06-01
Product CodeDKE
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SPEC(TM) EXTRACTION CARTRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Toxi-Lab, Inc.. It received FDA 510(k) clearance on 1990-06-01 under 510(k) number K901694. The device is classified under product code DKE. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPEC(TM) EXTRACTION CARTRIDGE?

SPEC(TM) EXTRACTION CARTRIDGE is a medical device that received FDA 510(k) clearance on 1990-06-01. The listed applicant is Toxi-Lab, Inc.. The 510(k) number is K901694.

When did SPEC(TM) EXTRACTION CARTRIDGE receive FDA 510(k) clearance?

SPEC(TM) EXTRACTION CARTRIDGE received FDA 510(k) clearance on 1990-06-01, under 510(k) number K901694.

Who is the listed applicant for SPEC(TM) EXTRACTION CARTRIDGE?

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

What is the FDA product code for SPEC(TM) EXTRACTION CARTRIDGE?

The FDA product code for SPEC(TM) EXTRACTION CARTRIDGE is DKE.

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.

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Other records listing Toxi-Lab, 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.

K932209TOXI*LAB LTD OPIATE SYSTEMK923337ON*SITE ALCOHOLK903223ON-SITE ALCOHOLK900626ALPHA URINE SAMPLE

Related Devices (Code: DKE)

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.

K003687VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COCMedtox Diagnostics, Inc.K994405INSTANT-VIEW MARIJUANA URINE CASSETTE TESTAlfa Scientific Designs, Inc.K992068STATUS STIK, ACCUSIGN STIKPrinceton BioMeditech Corp.K991751STATUS CUP ACCUSIGN CUPPrinceton BioMeditech Corp.K991078ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8Princeton BioMeditech Corp.K983147ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/PPrinceton BioMeditech Corp.

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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