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FDA 510(k)

AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT

K-Number: K851104 · 1985-04-10

ApplicantAmersham Corp.
Decision Date1985-04-10
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1985-04-10 under 510(k) number K851104. 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 AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT?

AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT is a medical device that received FDA 510(k) clearance on 1985-04-10. The listed applicant is Amersham Corp.. The 510(k) number is K851104.

When did AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT receive FDA 510(k) clearance?

AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT received FDA 510(k) clearance on 1985-04-10, under 510(k) number K851104.

Who is the listed applicant for AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT?

The FDA 510(k) record lists Amersham Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT?

The FDA product code for AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT is CEP.

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Other records listing Amersham Corp. as applicant

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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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