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FDA 510(k)

IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS

K-Number: K051626 · 2005-10-13

ApplicantImmunalysis Corporation
Decision Date2005-10-13
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IMMUNALYSIS OPIATES 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 2005-10-13 under 510(k) number K051626. 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 IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS?

IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS is a medical device that received FDA 510(k) clearance on 2005-10-13. The listed applicant is Immunalysis Corporation. The 510(k) number is K051626.

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

IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS received FDA 510(k) clearance on 2005-10-13, under 510(k) number K051626.

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

The FDA product code for IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS is DJG.

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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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