FDA 510(k)

RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST

K-Number: K993519 · 2000-01-14

ApplicantCardiovascular Diagnostics, Inc.

Decision Date2000-01-14

Product CodeJOX

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Diagnostics, Inc.. It received FDA 510(k) clearance on 2000-01-14 under 510(k) number K993519. The device is classified under product code JOX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST?

RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST is a medical device that received FDA 510(k) clearance on 2000-01-14. The listed applicant is Cardiovascular Diagnostics, Inc.. The 510(k) number is K993519.

When did RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST receive FDA 510(k) clearance?

RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST received FDA 510(k) clearance on 2000-01-14, under 510(k) number K993519.

Who is the listed applicant for RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST?

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

What is the FDA product code for RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST?

The FDA product code for RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST is JOX.

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Other records listing Cardiovascular Diagnostics, Inc. as applicant

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Related Devices (Code: JOX)

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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.