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FDA 510(k)

CS137 SEALED SOURCES

K-Number: K850434 · 1985-03-26

ApplicantSyncor Intl. Corp.
Decision Date1985-03-26
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CS137 SEALED SOURCES is the device name listed in this FDA 510(k) record. The listed applicant is Syncor Intl. Corp.. It received FDA 510(k) clearance on 1985-03-26 under 510(k) number K850434. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CS137 SEALED SOURCES?

CS137 SEALED SOURCES is a medical device that received FDA 510(k) clearance on 1985-03-26. The listed applicant is Syncor Intl. Corp.. The 510(k) number is K850434.

When did CS137 SEALED SOURCES receive FDA 510(k) clearance?

CS137 SEALED SOURCES received FDA 510(k) clearance on 1985-03-26, under 510(k) number K850434.

Who is the listed applicant for CS137 SEALED SOURCES?

The FDA 510(k) record lists Syncor Intl. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CS137 SEALED SOURCES?

The FDA product code for CS137 SEALED SOURCES is KXK.

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Other records listing Syncor Intl. Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K945825SECURE SAFETY INSERTK851828IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-CK850433CESIUM 137 ENDOMETRIAL SOURCEK852023CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41K852665SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAYK851033SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT

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Related Devices (Code: KXK)

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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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