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FDA 510(k)

IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE)

K-Number: K041746 · 2004-11-23

ApplicantLifepoint,Inc
Decision Date2004-11-23
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE) is the device name listed in this FDA 510(k) record. The listed applicant is Lifepoint,Inc. It received FDA 510(k) clearance on 2004-11-23 under 510(k) number K041746. 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 IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE)?

IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE) is a medical device that received FDA 510(k) clearance on 2004-11-23. The listed applicant is Lifepoint,Inc. The 510(k) number is K041746.

When did IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE) receive FDA 510(k) clearance?

IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE) received FDA 510(k) clearance on 2004-11-23, under 510(k) number K041746.

Who is the listed applicant for IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE)?

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

What is the FDA product code for IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE)?

The FDA product code for IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE) is DJG.

Related Clinical Trials

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Other records listing Lifepoint,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.

K041747IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE)K833737CPR LOCATOR

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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