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FDA 510(k)

GOLD(AU 195) SPOT MARKER SOURCES

K-Number: K812235 · 1981-09-09

ApplicantAmersham Corp.
Decision Date1981-09-09
Product CodeIXD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GOLD(AU 195) SPOT MARKER SOURCES is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1981-09-09 under 510(k) number K812235. The device is classified under product code IXD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOLD(AU 195) SPOT MARKER SOURCES?

GOLD(AU 195) SPOT MARKER SOURCES is a medical device that received FDA 510(k) clearance on 1981-09-09. The listed applicant is Amersham Corp.. The 510(k) number is K812235.

When did GOLD(AU 195) SPOT MARKER SOURCES receive FDA 510(k) clearance?

GOLD(AU 195) SPOT MARKER SOURCES received FDA 510(k) clearance on 1981-09-09, under 510(k) number K812235.

Who is the listed applicant for GOLD(AU 195) SPOT MARKER SOURCES?

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 GOLD(AU 195) SPOT MARKER SOURCES?

The FDA product code for GOLD(AU 195) SPOT MARKER SOURCES is IXD.

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Official Source

View on FDA Database →

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