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FDA 510(k)

DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR

K-Number: K983693 · 1998-11-04

ApplicantDade Behring, Inc.
Decision Date1998-11-04
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 1998-11-04 under 510(k) number K983693. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR?

DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR is a medical device that received FDA 510(k) clearance on 1998-11-04. The listed applicant is Dade Behring, Inc.. The 510(k) number is K983693.

When did DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR receive FDA 510(k) clearance?

DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR received FDA 510(k) clearance on 1998-11-04, under 510(k) number K983693.

Who is the listed applicant for DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR?

The FDA 510(k) record lists Dade Behring, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR?

The FDA product code for DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR is JIT.

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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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