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FDA 510(k)

ST AIA-PACK CEA ENZYME IMMUNOASSAY

K-Number: K023893 · 2002-12-18

ApplicantTosoh Medics, Inc.
Decision Date2002-12-18
Product CodeDHX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ST AIA-PACK CEA ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Tosoh Medics, Inc.. It received FDA 510(k) clearance on 2002-12-18 under 510(k) number K023893. 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 ST AIA-PACK CEA ENZYME IMMUNOASSAY?

ST AIA-PACK CEA ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 2002-12-18. The listed applicant is Tosoh Medics, Inc.. The 510(k) number is K023893.

When did ST AIA-PACK CEA ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

ST AIA-PACK CEA ENZYME IMMUNOASSAY received FDA 510(k) clearance on 2002-12-18, under 510(k) number K023893.

Who is the listed applicant for ST AIA-PACK CEA ENZYME IMMUNOASSAY?

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

What is the FDA product code for ST AIA-PACK CEA ENZYME IMMUNOASSAY?

The FDA product code for ST AIA-PACK CEA ENZYME IMMUNOASSAY is DHX.

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Other records listing Tosoh Medics, 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.

K023091ST AIA-PACK TESTOSTERONE ASSAYK023894ST AIA-PACK AFP ENZYME IMMUNOASSAYK023891ST AIA-PACK CA 125 ENZYME IMMUNOASSAYK020489G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODEK012820AIA-PACK CTNI 2ND-GEN ASSAYK011434G7 AUTOMATED HPLC ANALYZER

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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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