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FDA 510(k)

AMERLEX LH RIA KIT (CODE IM2081)

K-Number: K820753 · 1982-04-09

ApplicantAmersham Corp.
Decision Date1982-04-09
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMERLEX LH RIA KIT (CODE IM2081) is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1982-04-09 under 510(k) number K820753. 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 LH RIA KIT (CODE IM2081)?

AMERLEX LH RIA KIT (CODE IM2081) is a medical device that received FDA 510(k) clearance on 1982-04-09. The listed applicant is Amersham Corp.. The 510(k) number is K820753.

When did AMERLEX LH RIA KIT (CODE IM2081) receive FDA 510(k) clearance?

AMERLEX LH RIA KIT (CODE IM2081) received FDA 510(k) clearance on 1982-04-09, under 510(k) number K820753.

Who is the listed applicant for AMERLEX LH RIA KIT (CODE IM2081)?

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 LH RIA KIT (CODE IM2081)?

The FDA product code for AMERLEX LH RIA KIT (CODE IM2081) is CEP.

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Other records listing Amersham Corp. as applicant

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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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