FDA 510(k)

TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET

K-Number: K093032 · 2009-11-13

Decision Date2009-11-13

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET is the device name listed in this FDA 510(k) record. The listed applicant is Biosite Incorporated. It received FDA 510(k) clearance on 2009-11-13 under 510(k) number K093032. 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 TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET?

TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET is a medical device that received FDA 510(k) clearance on 2009-11-13. The listed applicant is Biosite Incorporated. The 510(k) number is K093032.

When did TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET receive FDA 510(k) clearance?

TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET received FDA 510(k) clearance on 2009-11-13, under 510(k) number K093032.

Who is the listed applicant for TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET?

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 TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET?

The FDA product code for TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET is JJY.

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Other records listing Biosite Incorporated as applicant

K092987INRATIO/INRATIO2 TEST STRIPS K092048ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP 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 K062530TRIAGE PROTEIN C 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.