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FDA 510(k)

CEDIA DIGOXIN CALIBRATORS

K-Number: K972433 · 1997-07-24

ApplicantBoehringer Mannheim Corp.
Decision Date1997-07-24
Product CodeDLJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CEDIA DIGOXIN CALIBRATORS 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 1997-07-24 under 510(k) number K972433. The device is classified under product code DLJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEDIA DIGOXIN CALIBRATORS?

CEDIA DIGOXIN CALIBRATORS is a medical device that received FDA 510(k) clearance on 1997-07-24. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K972433.

When did CEDIA DIGOXIN CALIBRATORS receive FDA 510(k) clearance?

CEDIA DIGOXIN CALIBRATORS received FDA 510(k) clearance on 1997-07-24, under 510(k) number K972433.

Who is the listed applicant for CEDIA DIGOXIN CALIBRATORS?

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 CEDIA DIGOXIN CALIBRATORS?

The FDA product code for CEDIA DIGOXIN CALIBRATORS is DLJ.

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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.

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Related Devices (Code: DLJ)

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K132090BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2Randox Laboratories, Ltd.K091617QMS LIDOCAINE CALIBRATORS, MODEL 0374678Thermo Fisher ScientificK082030DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440Siemens Healthcare Diagnostics, Inc.K062182DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520Dade Behring, Inc.K062199DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)Dade Behring, Inc.K061503DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)Dade 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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