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FDA 510(k)

LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA

K-Number: K873186 · 1987-09-29

ApplicantSerono Diagnostics, Inc.
Decision Date1987-09-29
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA 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 1987-09-29 under 510(k) number K873186. The device is classified under product code CEP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA?

LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA is a medical device that received FDA 510(k) clearance on 1987-09-29. The listed applicant is Serono Diagnostics, Inc.. The 510(k) number is K873186.

When did LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA receive FDA 510(k) clearance?

LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA received FDA 510(k) clearance on 1987-09-29, under 510(k) number K873186.

Who is the listed applicant for LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA?

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 LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA?

The FDA product code for LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA is CEP.

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Related Devices (Code: CEP)

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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