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FDA 510(k)

RAMP NT-PROBNP ASSAY

K-Number: K063662 · 2008-07-21

ApplicantResponse Biomedical Corp.
Decision Date2008-07-21
Product CodeNBC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAMP NT-PROBNP ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Response Biomedical Corp.. It received FDA 510(k) clearance on 2008-07-21 under 510(k) number K063662. The device is classified under product code NBC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAMP NT-PROBNP ASSAY?

RAMP NT-PROBNP ASSAY is a medical device that received FDA 510(k) clearance on 2008-07-21. The listed applicant is Response Biomedical Corp.. The 510(k) number is K063662.

When did RAMP NT-PROBNP ASSAY receive FDA 510(k) clearance?

RAMP NT-PROBNP ASSAY received FDA 510(k) clearance on 2008-07-21, under 510(k) number K063662.

Who is the listed applicant for RAMP NT-PROBNP ASSAY?

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

What is the FDA product code for RAMP NT-PROBNP ASSAY?

The FDA product code for RAMP NT-PROBNP ASSAY is NBC.

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Other records listing Response Biomedical Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K093116MODIFICATION TO: RAMP INFLUENZA A/B ASSAYK091235RAMP RSV ASSAYK071591RAMP INFLUENZA A/B ASSAYK033745RAMP TROPONIN I ASSAYK033747RAMP CK-MB ASSAYK012040RAMP MYOGLOBIN ASSAY

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Related Devices (Code: NBC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262109Access NT-proBNPBeckman Coulter, Inc.K252169Access BNP IIBeckman Coulter, Inc.K253539Alere NT-proBNP for Alinity iAxis-Shield Diagnostics, Ltd.K241176Alere NT-proBNP for Alinity i Reagent KitAxis-Shield Diagnostics, Ltd.K232164Access NT-proBNPBeckman Coulter, Inc.K220265ADVIA Centaur® NT-proBNPII (PBNPII)Siemens Healthcare Diagnostics, Inc.

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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