FDA 510(k)

THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS

K-Number: K981178 · 1998-04-27

ApplicantCardiovascular Diagnostics, Inc.

Decision Date1998-04-27

Product CodeGGN

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS 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 1998-04-27 under 510(k) number K981178. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS?

THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS is a medical device that received FDA 510(k) clearance on 1998-04-27. The listed applicant is Cardiovascular Diagnostics, Inc.. The 510(k) number is K981178.

When did THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS receive FDA 510(k) clearance?

THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS received FDA 510(k) clearance on 1998-04-27, under 510(k) number K981178.

Who is the listed applicant for THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS?

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 THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS?

The FDA product code for THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS is GGN.

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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.