FDA 510(k)

HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS

K-Number: K862262 · 1986-07-29

Decision Date1986-07-29

Product CodeJHI

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Serono Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-07-29 under 510(k) number K862262. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS?

HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS is a medical device that received FDA 510(k) clearance on 1986-07-29. The listed applicant is Serono Diagnostics, Inc.. The 510(k) number is K862262.

When did HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS receive FDA 510(k) clearance?

HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS received FDA 510(k) clearance on 1986-07-29, under 510(k) number K862262.

Who is the listed applicant for HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS?

The FDA 510(k) record lists Serono Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS?

The FDA product code for HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS is JHI.

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Related Devices (Code: JHI)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.