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FDA 510(k)

IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS

K-Number: K051577 · 2005-10-04

ApplicantImmunalysis Corporation
Decision Date2005-10-04
Product CodeLAF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS is the device name listed in this FDA 510(k) record. The listed applicant is Immunalysis Corporation. It received FDA 510(k) clearance on 2005-10-04 under 510(k) number K051577. The device is classified under product code LAF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS?

IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS is a medical device that received FDA 510(k) clearance on 2005-10-04. The listed applicant is Immunalysis Corporation. The 510(k) number is K051577.

When did IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS receive FDA 510(k) clearance?

IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS received FDA 510(k) clearance on 2005-10-04, under 510(k) number K051577.

Who is the listed applicant for IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS?

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

What is the FDA product code for IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS?

The FDA product code for IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS is LAF.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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