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FDA 510(k)

TRIAGE BNP CALIBRATION VERIFICATION CONTROLS

K-Number: K000231 · 2000-03-02

ApplicantBiosite Incorporated
Decision Date2000-03-02
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRIAGE BNP CALIBRATION VERIFICATION 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 2000-03-02 under 510(k) number K000231. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIAGE BNP CALIBRATION VERIFICATION CONTROLS?

TRIAGE BNP CALIBRATION VERIFICATION CONTROLS is a medical device that received FDA 510(k) clearance on 2000-03-02. The listed applicant is Biosite Incorporated. The 510(k) number is K000231.

When did TRIAGE BNP CALIBRATION VERIFICATION CONTROLS receive FDA 510(k) clearance?

TRIAGE BNP CALIBRATION VERIFICATION CONTROLS received FDA 510(k) clearance on 2000-03-02, under 510(k) number K000231.

Who is the listed applicant for TRIAGE BNP CALIBRATION VERIFICATION 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 BNP CALIBRATION VERIFICATION CONTROLS?

The FDA product code for TRIAGE BNP CALIBRATION VERIFICATION CONTROLS is JJX.

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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.

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