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FDA 510(k)

RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125]

K-Number: K871698 · 1987-06-15

ApplicantImmunalysis Corporation
Decision Date1987-06-15
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RESUBMISSION OF URINE HEROIN/MORPHINE 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 1987-06-15 under 510(k) number K871698. 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 RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125]?

RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125] is a medical device that received FDA 510(k) clearance on 1987-06-15. The listed applicant is Immunalysis Corporation. The 510(k) number is K871698.

When did RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125] receive FDA 510(k) clearance?

RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125] received FDA 510(k) clearance on 1987-06-15, under 510(k) number K871698.

Who is the listed applicant for RESUBMISSION OF URINE HEROIN/MORPHINE 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 RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125]?

The FDA product code for RESUBMISSION OF URINE HEROIN/MORPHINE 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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