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FDA 510(k)

CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL

K-Number: K792377 · 1980-09-26

ApplicantEnvironmental Chemical Specialties
Decision Date1980-09-26
Product CodeDHX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Environmental Chemical Specialties. It received FDA 510(k) clearance on 1980-09-26 under 510(k) number K792377. 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 CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL?

CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL is a medical device that received FDA 510(k) clearance on 1980-09-26. The listed applicant is Environmental Chemical Specialties. The 510(k) number is K792377.

When did CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL receive FDA 510(k) clearance?

CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL received FDA 510(k) clearance on 1980-09-26, under 510(k) number K792377.

Who is the listed applicant for CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL?

The FDA 510(k) record lists Environmental Chemical Specialties as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL?

The FDA product code for CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL is DHX.

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Other records listing Environmental Chemical Specialties 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.

K812635ANEMIA CONTROLK811810URIC ACID TESTK811811TDM ANTI-CONVULSANT CONTROL LEVELS I-IIK811809ANTI-ARRHYTHMIC CONTROL LEVELS I & IIK803089GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT)K801854SPINAL FLUID CONTROL(HUMAN)

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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

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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