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FDA 510(k)

CEA DESALTING DOLUMN SEPHADEX R

K-Number: K811394 · 1981-06-12

ApplicantImmuno-Diagnostic Laboratories
Decision Date1981-06-12
Product CodeDHX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CEA DESALTING DOLUMN SEPHADEX R is the device name listed in this FDA 510(k) record. The listed applicant is Immuno-Diagnostic Laboratories. It received FDA 510(k) clearance on 1981-06-12 under 510(k) number K811394. The device is classified under product code DHX. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEA DESALTING DOLUMN SEPHADEX R?

CEA DESALTING DOLUMN SEPHADEX R is a medical device that received FDA 510(k) clearance on 1981-06-12. The listed applicant is Immuno-Diagnostic Laboratories. The 510(k) number is K811394.

When did CEA DESALTING DOLUMN SEPHADEX R receive FDA 510(k) clearance?

CEA DESALTING DOLUMN SEPHADEX R received FDA 510(k) clearance on 1981-06-12, under 510(k) number K811394.

Who is the listed applicant for CEA DESALTING DOLUMN SEPHADEX R?

The FDA 510(k) record lists Immuno-Diagnostic Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CEA DESALTING DOLUMN SEPHADEX R?

The FDA product code for CEA DESALTING DOLUMN SEPHADEX R is DHX.

Related Clinical Trials

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Other records listing Immuno-Diagnostic Laboratories 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.

K833777ANGIOTENSIN CONVERTING ENZYME

Related Devices (Code: DHX)

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.

K223921Access CEABeckman Coulter, Inc.K231517VITROS Immunodiagnostic Products CEA Reagent PackOrtho Clinical DiagnosticsK200215ADVIA Centaur CEA AssaySiemens Healthcare Disgnostics, Inc.K081615OLYMPUS CEA - CARCINOEMBRYONIC ANTIGENOlympus America, Inc.K080194VIDAS CEA (S) ASSAYbioMerieux, Inc.K071603DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)Dade Behring, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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