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FDA 510(k)

URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)

K-Number: K913863 · 1991-09-19

ApplicantImmunalysis Corporation
Decision Date1991-09-19
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) is the device name listed in this FDA 510(k) record. The listed applicant is Immunalysis Corporation. It received FDA 510(k) clearance on 1991-09-19 under 510(k) number K913863. 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 URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)?

URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) is a medical device that received FDA 510(k) clearance on 1991-09-19. The listed applicant is Immunalysis Corporation. The 510(k) number is K913863.

When did URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) receive FDA 510(k) clearance?

URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) received FDA 510(k) clearance on 1991-09-19, under 510(k) number K913863.

Who is the listed applicant for URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)?

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 URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)?

The FDA product code for URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) is DJG.

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Related Devices (Code: 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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