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FDA 510(k)

IMX CA 125

K-Number: K964185 · 1997-11-04

ApplicantAbbott Diagnostics
Decision Date1997-11-04
Product CodeLTK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMX CA 125 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diagnostics. It received FDA 510(k) clearance on 1997-11-04 under 510(k) number K964185. 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 IMX CA 125?

IMX CA 125 is a medical device that received FDA 510(k) clearance on 1997-11-04. The listed applicant is Abbott Diagnostics. The 510(k) number is K964185.

When did IMX CA 125 receive FDA 510(k) clearance?

IMX CA 125 received FDA 510(k) clearance on 1997-11-04, under 510(k) number K964185.

Who is the listed applicant for IMX CA 125?

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

What is the FDA product code for IMX CA 125?

The FDA product code for IMX CA 125 is LTK.

Other records listing Abbott Diagnostics 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.

K972182ABBOTT STREP A CONTROLSK961439ABBOTT CELL-DYN 4000 SYSTEMK890491CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYERK881242CELL-DYN RAPID-LYSE AND HEMOGLOBLINK881130CELL-DYN ISOTONIC DILUENTK873348CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.

View all 28 devices →

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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