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FDA 510(k)

ST AIA-PACK AFP ENZYME IMMUNOASSAY

K-Number: K023894 · 2002-12-17

ApplicantTosoh Medics, Inc.
Decision Date2002-12-17
Product CodeLOJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ST AIA-PACK AFP 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 2002-12-17 under 510(k) number K023894. The device is classified under product code LOJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ST AIA-PACK AFP ENZYME IMMUNOASSAY?

ST AIA-PACK AFP ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 2002-12-17. The listed applicant is Tosoh Medics, Inc.. The 510(k) number is K023894.

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

ST AIA-PACK AFP ENZYME IMMUNOASSAY received FDA 510(k) clearance on 2002-12-17, under 510(k) number K023894.

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

The FDA product code for ST AIA-PACK AFP ENZYME IMMUNOASSAY is LOJ.

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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.

K023893ST AIA-PACK CEA ENZYME IMMUNOASSAYK023091ST AIA-PACK TESTOSTERONE ASSAYK023891ST 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: LOJ)

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.

K220176Elecsys AFPRoche DiagnosticsK213626VITROS AFPOrtho Clinical DiagnosticsK090236DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454Siemens Healthcare DiagnosticsK081709OLYMPUS AFP - ALPHA-FETOPROTEINOlympus Life Science Research Europa GmbH (Europa)K080017VIDAS AFP ASSAYbioMerieux, Inc.K071597DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600Dade 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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