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FDA 510(k)

AMERLEX-M B-HUMAN CHORIONIC GONADTROPIN RADIOI KIT

K-Number: K852675 · 1985-07-22

ApplicantAmersham Corp.
Decision Date1985-07-22
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMERLEX-M B-HUMAN CHORIONIC GONADTROPIN RADIOI 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 1985-07-22 under 510(k) number K852675. 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-M B-HUMAN CHORIONIC GONADTROPIN RADIOI KIT?

AMERLEX-M B-HUMAN CHORIONIC GONADTROPIN RADIOI KIT is a medical device that received FDA 510(k) clearance on 1985-07-22. The listed applicant is Amersham Corp.. The 510(k) number is K852675.

When did AMERLEX-M B-HUMAN CHORIONIC GONADTROPIN RADIOI KIT receive FDA 510(k) clearance?

AMERLEX-M B-HUMAN CHORIONIC GONADTROPIN RADIOI KIT received FDA 510(k) clearance on 1985-07-22, under 510(k) number K852675.

Who is the listed applicant for AMERLEX-M B-HUMAN CHORIONIC GONADTROPIN RADIOI 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 B-HUMAN CHORIONIC GONADTROPIN RADIOI KIT?

The FDA product code for AMERLEX-M B-HUMAN CHORIONIC GONADTROPIN RADIOI KIT is JHI.

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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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