FDA 510(k)

ELECSYS DIGOXIN

K-Number: K973112 · 1997-10-10

Decision Date1997-10-10

Product CodeKXT

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

ELECSYS DIGOXIN 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 1997-10-10 under 510(k) number K973112. The device is classified under product code KXT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECSYS DIGOXIN?

ELECSYS DIGOXIN is a medical device that received FDA 510(k) clearance on 1997-10-10. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K973112.

When did ELECSYS DIGOXIN receive FDA 510(k) clearance?

ELECSYS DIGOXIN received FDA 510(k) clearance on 1997-10-10, under 510(k) number K973112.

Who is the listed applicant for ELECSYS DIGOXIN?

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 DIGOXIN?

The FDA product code for ELECSYS DIGOXIN is KXT.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Boehringer Mannheim Corp. as applicant

K984326ELECYS IGE ASSAY K983047ACCU-CHEK HQ SYSTEM K984419ELECSYS IGE CALCHECK K984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR K984372ELECSYS CALCHECK TROPONIN T K984105ELECSYS TROPONIN T STAT TEST

View all 340 devices →

Related Devices (Code: KXT)

K193397ADVIA Centaur® Digoxin assaySiemens Healthcare Diagnostics, Inc.K153301Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac IIRoche Diagnostics K102346RANDOX DIGOXIN ASSAYRandox Laboratories, Ltd.K093441DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435Siemens Healthcare Diagnostics K082953ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01Biokit, S.A.K061249AXSYM DIGOXIN IIIAbbott Laboratories

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.