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FDA 510(k)

PCP DIRECT RIA KIT (I-125)

K-Number: K913864 · 1991-10-11

ApplicantImmunalysis Corporation
Decision Date1991-10-11
Product CodeLCL
DecisionSubstantially Equivalent

Device Summary

PCP 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 1991-10-11 under 510(k) number K913864. The device is classified under product code LCL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PCP DIRECT RIA KIT (I-125)?

PCP DIRECT RIA KIT (I-125) is a medical device that received FDA 510(k) clearance on 1991-10-11. The listed applicant is Immunalysis Corporation. The 510(k) number is K913864.

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

PCP DIRECT RIA KIT (I-125) received FDA 510(k) clearance on 1991-10-11, under 510(k) number K913864.

Who is the listed applicant for PCP 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 PCP DIRECT RIA KIT (I-125)?

The FDA product code for PCP DIRECT RIA KIT (I-125) is LCL.

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Related Devices (Code: LCL)

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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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