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FDA 510(k)

URINE COCAINE METABOLITE DIRECT RIA KIT (I-125)

K-Number: K913867 · 1991-09-19

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

Device Summary

URINE COCAINE METABOLITE 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 K913867. The device is classified under product code KLN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URINE COCAINE METABOLITE DIRECT RIA KIT (I-125)?

URINE COCAINE METABOLITE 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 K913867.

When did URINE COCAINE METABOLITE DIRECT RIA KIT (I-125) receive FDA 510(k) clearance?

URINE COCAINE METABOLITE DIRECT RIA KIT (I-125) received FDA 510(k) clearance on 1991-09-19, under 510(k) number K913867.

Who is the listed applicant for URINE COCAINE METABOLITE 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 COCAINE METABOLITE DIRECT RIA KIT (I-125)?

The FDA product code for URINE COCAINE METABOLITE DIRECT RIA KIT (I-125) is KLN.

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Related Devices (Code: KLN)

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

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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