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FDA 510(k)

ST AIA-PACK CA 125 ENZYME IMMUNOASSAY

K-Number: K023891 · 2002-12-06

ApplicantTosoh Medics, Inc.
Decision Date2002-12-06
Product CodeLTK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ST AIA-PACK CA 125 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 2002-12-06 under 510(k) number K023891. The device is classified under product code LTK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ST AIA-PACK CA 125 ENZYME IMMUNOASSAY?

ST AIA-PACK CA 125 ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 2002-12-06. The listed applicant is Tosoh Medics, Inc.. The 510(k) number is K023891.

When did ST AIA-PACK CA 125 ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

ST AIA-PACK CA 125 ENZYME IMMUNOASSAY received FDA 510(k) clearance on 2002-12-06, under 510(k) number K023891.

Who is the listed applicant for ST AIA-PACK CA 125 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 CA 125 ENZYME IMMUNOASSAY?

The FDA product code for ST AIA-PACK CA 125 ENZYME IMMUNOASSAY is LTK.

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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 ASSAYK023894ST AIA-PACK AFP ENZYME IMMUNOASSAYK020489G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODEK012820AIA-PACK CTNI 2ND-GEN ASSAYK011434G7 AUTOMATED HPLC ANALYZER

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Related Devices (Code: LTK)

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.

K240479Access OV MonitorBeckman Coulter, Inc.K213510IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MASiemens Healthcare Diagnostics Products, Ltd.K221355VITROS Immuodiagnostic Products CA 125 II Reagent PackOrtho Clinical DiagnosticsK200199ADVIA Centaur CA 125IISiemens Healthcare Diagnostics, Inc.K100321DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604Siemens Healthcare DiagnosticsK080469VIDAS CA 15-3 ASSAYbioMerieux, 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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