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FDA 510(k)

AMERLEX B-LCG RIA KIT

K-Number: K821031 · 1982-05-03

ApplicantAmersham Corp.
Decision Date1982-05-03
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMERLEX B-LCG RIA 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 1982-05-03 under 510(k) number K821031. 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 AMERLEX B-LCG RIA KIT?

AMERLEX B-LCG RIA KIT is a medical device that received FDA 510(k) clearance on 1982-05-03. The listed applicant is Amersham Corp.. The 510(k) number is K821031.

When did AMERLEX B-LCG RIA KIT receive FDA 510(k) clearance?

AMERLEX B-LCG RIA KIT received FDA 510(k) clearance on 1982-05-03, under 510(k) number K821031.

Who is the listed applicant for AMERLEX B-LCG RIA 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 B-LCG RIA KIT?

The FDA product code for AMERLEX B-LCG RIA KIT is JHI.

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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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