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FDA 510(k)

IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE)

K-Number: K041747 · 2004-11-24

ApplicantLifepoint,Inc
Decision Date2004-11-24
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE) is the device name listed in this FDA 510(k) record. The listed applicant is Lifepoint,Inc. It received FDA 510(k) clearance on 2004-11-24 under 510(k) number K041747. 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 (WORKPLACE)?

IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE) is a medical device that received FDA 510(k) clearance on 2004-11-24. The listed applicant is Lifepoint,Inc. The 510(k) number is K041747.

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

IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE) received FDA 510(k) clearance on 2004-11-24, under 510(k) number K041747.

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

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 (WORKPLACE)?

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

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 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.

K041746IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE)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.

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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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