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FDA 510(k)

CENTRIA RADIOIMMUNOASSAY SEPARATION

K-Number: K792636 · 1980-01-11

ApplicantUnion Carbide Corp.
Decision Date1980-01-11
Product CodeKTS
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CENTRIA RADIOIMMUNOASSAY SEPARATION is the device name listed in this FDA 510(k) record. The listed applicant is Union Carbide Corp.. It received FDA 510(k) clearance on 1980-01-11 under 510(k) number K792636. The device is classified under product code KTS. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTRIA RADIOIMMUNOASSAY SEPARATION?

CENTRIA RADIOIMMUNOASSAY SEPARATION is a medical device that received FDA 510(k) clearance on 1980-01-11. The listed applicant is Union Carbide Corp.. The 510(k) number is K792636.

When did CENTRIA RADIOIMMUNOASSAY SEPARATION receive FDA 510(k) clearance?

CENTRIA RADIOIMMUNOASSAY SEPARATION received FDA 510(k) clearance on 1980-01-11, under 510(k) number K792636.

Who is the listed applicant for CENTRIA RADIOIMMUNOASSAY SEPARATION?

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

What is the FDA product code for CENTRIA RADIOIMMUNOASSAY SEPARATION?

The FDA product code for CENTRIA RADIOIMMUNOASSAY SEPARATION is KTS.

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Other records listing Union Carbide 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.

K830337MARK III OXYGEN WALKER SYS-LOW PRESSK820836MARK III OXYGEN WALKER SYSTEMK820535LASER GAS MIXTURESK812536LINDE MARK IIK810732LINDE MARK II OXYGEN RESERV. TYPE OR-4K810596CENTRIFI CHEM SYSTEM 400 ANALYZER

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Related Devices (Code: KTS)

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.

K813508SAC-CELBurroughs Wellcome Co.K792637CENTRIA-SET TYPE D(ANTI-SHEEP/GOAT)Union Carbide Corp.K781070SECOND ANTIBODYPcl-Ria, Inc.

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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