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FDA 510(k)

CARDIAC TROPONIN-I (TROP) CALIBRATOR

K-Number: K973668 · 1997-10-20

ApplicantDade Intl., Inc.
Decision Date1997-10-20
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARDIAC TROPONIN-I (TROP) CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Dade Intl., Inc.. It received FDA 510(k) clearance on 1997-10-20 under 510(k) number K973668. 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 CARDIAC TROPONIN-I (TROP) CALIBRATOR?

CARDIAC TROPONIN-I (TROP) CALIBRATOR is a medical device that received FDA 510(k) clearance on 1997-10-20. The listed applicant is Dade Intl., Inc.. The 510(k) number is K973668.

When did CARDIAC TROPONIN-I (TROP) CALIBRATOR receive FDA 510(k) clearance?

CARDIAC TROPONIN-I (TROP) CALIBRATOR received FDA 510(k) clearance on 1997-10-20, under 510(k) number K973668.

Who is the listed applicant for CARDIAC TROPONIN-I (TROP) CALIBRATOR?

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

What is the FDA product code for CARDIAC TROPONIN-I (TROP) CALIBRATOR?

The FDA product code for CARDIAC TROPONIN-I (TROP) CALIBRATOR is JIT.

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Other records listing Dade Intl., Inc. as applicant

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Related Devices (Code: 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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