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FDA 510(k)

TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS

K-Number: K000230 · 2000-02-29

ApplicantBiosite Incorporated
Decision Date2000-02-29
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) 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 2000-02-29 under 510(k) number K000230. 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 B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS?

TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS is a medical device that received FDA 510(k) clearance on 2000-02-29. The listed applicant is Biosite Incorporated. The 510(k) number is K000230.

When did TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS receive FDA 510(k) clearance?

TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS received FDA 510(k) clearance on 2000-02-29, under 510(k) number K000230.

Who is the listed applicant for TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) 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 B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS?

The FDA product code for TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) 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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