FDA 510(k)

CARDIOQUANT CARDIAC ASSESSMENT CONTROLS

K-Number: K991447 · 1999-06-11

Decision Date1999-06-11

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

CARDIOQUANT CARDIAC ASSESSMENT CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Spectral Diagnostics, Inc.. It received FDA 510(k) clearance on 1999-06-11 under 510(k) number K991447. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOQUANT CARDIAC ASSESSMENT CONTROLS?

CARDIOQUANT CARDIAC ASSESSMENT CONTROLS is a medical device that received FDA 510(k) clearance on 1999-06-11. The listed applicant is Spectral Diagnostics, Inc.. The 510(k) number is K991447.

When did CARDIOQUANT CARDIAC ASSESSMENT CONTROLS receive FDA 510(k) clearance?

CARDIOQUANT CARDIAC ASSESSMENT CONTROLS received FDA 510(k) clearance on 1999-06-11, under 510(k) number K991447.

Who is the listed applicant for CARDIOQUANT CARDIAC ASSESSMENT CONTROLS?

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

What is the FDA product code for CARDIOQUANT CARDIAC ASSESSMENT CONTROLS?

The FDA product code for CARDIOQUANT CARDIAC ASSESSMENT CONTROLS is JJY.

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Other records listing Spectral Diagnostics, Inc. as applicant

K052519SPECTRAL WEST NILE VIRUS IGM STATUS TEST K030057SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST K022409SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST K020950SPECTRAL'S 2 IN 1 (TNI-MYO)K014105SPECTRAL'S TROPONIN I K992127CARDIOQUANT TROPONIN I TEST

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.