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FDA 510(k)

AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE)

K-Number: K890708 · 1989-03-20

ApplicantAmersham Corp.
Decision Date1989-03-20
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE) is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1989-03-20 under 510(k) number K890708. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE)?

AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE) is a medical device that received FDA 510(k) clearance on 1989-03-20. The listed applicant is Amersham Corp.. The 510(k) number is K890708.

When did AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE) receive FDA 510(k) clearance?

AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE) received FDA 510(k) clearance on 1989-03-20, under 510(k) number K890708.

Who is the listed applicant for AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE)?

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 AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE)?

The FDA product code for AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE) is JJY.

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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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