FDA 510(k)

TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS

K-Number: K030089 · 2003-01-23

Decision Date2003-01-23

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Biosite Incorporated. It received FDA 510(k) clearance on 2003-01-23 under 510(k) number K030089. 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 TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS?

TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS is a medical device that received FDA 510(k) clearance on 2003-01-23. The listed applicant is Biosite Incorporated. The 510(k) number is K030089.

When did TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS receive FDA 510(k) clearance?

TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS received FDA 510(k) clearance on 2003-01-23, under 510(k) number K030089.

Who is the listed applicant for TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS?

The FDA 510(k) record lists Biosite Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS?

The FDA product code for TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS is JJY.

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Other records listing Biosite Incorporated as applicant

K092987INRATIO/INRATIO2 TEST STRIPS K092048ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP K093032TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET K080269TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS K072892TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 K062840TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS

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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.