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FDA 510(k)

AMERLEX ESH KIT

K-Number: K820754 · 1982-04-15

ApplicantAmersham Corp.
Decision Date1982-04-15
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMERLEX ESH 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 1982-04-15 under 510(k) number K820754. The device is classified under product code CGJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERLEX ESH KIT?

AMERLEX ESH KIT is a medical device that received FDA 510(k) clearance on 1982-04-15. The listed applicant is Amersham Corp.. The 510(k) number is K820754.

When did AMERLEX ESH KIT receive FDA 510(k) clearance?

AMERLEX ESH KIT received FDA 510(k) clearance on 1982-04-15, under 510(k) number K820754.

Who is the listed applicant for AMERLEX ESH 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 ESH KIT?

The FDA product code for AMERLEX ESH KIT is CGJ.

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Other records listing Amersham Corp. as applicant

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Related Devices (Code: CGJ)

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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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