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FDA 510(k)

CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV

K-Number: K820298 · 1982-04-08

ApplicantVentrex Laboratories, Inc.
Decision Date1982-04-08
Product CodeDHX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV is the device name listed in this FDA 510(k) record. The listed applicant is Ventrex Laboratories, Inc.. It received FDA 510(k) clearance on 1982-04-08 under 510(k) number K820298. 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 CONTROL (4 LEV?

CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV is a medical device that received FDA 510(k) clearance on 1982-04-08. The listed applicant is Ventrex Laboratories, Inc.. The 510(k) number is K820298.

When did CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV receive FDA 510(k) clearance?

CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV received FDA 510(k) clearance on 1982-04-08, under 510(k) number K820298.

Who is the listed applicant for CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV?

The FDA 510(k) record lists Ventrex Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV?

The FDA product code for CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV is DHX.

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Other records listing Ventrex Laboratories, Inc. 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.

K914554SPECIFIC IGE EIA-TURBO ASSAYK913833VENTREX ALLERGEN DISCK913434VENTREX COATED TUBE INTACT PTHK905612VENTREX COATED TUBE IGE RADIOIMMUNOASSAYK905636VENTREX COATED TUBE IGE ENZYME IMMUNOASSAYK905247SHBG IRMA KIT

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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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