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FDA 510(k)

ELECSYS CA 125II ON THE ELECSYS 1010

K-Number: K980240 · 1998-03-25

ApplicantBoehringer Mannheim Corp.
Decision Date1998-03-25
Product CodeLTK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ELECSYS CA 125II ON THE ELECSYS 1010 is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1998-03-25 under 510(k) number K980240. 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 ELECSYS CA 125II ON THE ELECSYS 1010?

ELECSYS CA 125II ON THE ELECSYS 1010 is a medical device that received FDA 510(k) clearance on 1998-03-25. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K980240.

When did ELECSYS CA 125II ON THE ELECSYS 1010 receive FDA 510(k) clearance?

ELECSYS CA 125II ON THE ELECSYS 1010 received FDA 510(k) clearance on 1998-03-25, under 510(k) number K980240.

Who is the listed applicant for ELECSYS CA 125II ON THE ELECSYS 1010?

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

What is the FDA product code for ELECSYS CA 125II ON THE ELECSYS 1010?

The FDA product code for ELECSYS CA 125II ON THE ELECSYS 1010 is LTK.

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Other records listing Boehringer Mannheim Corp. 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.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TEST

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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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