Ramp Nt-Probnp Assay
FDA 510(k) K063662 · Response Biomedical Corp.
510(k) numberK063662
Submission
- Device name
- Ramp Nt-Probnp Assay
- Applicant
- Response Biomedical Corp.
Burnaby, British Columbia, CA - Received
- December 8, 2006
- Decision date
- July 21, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NBC – Test, Natriuretic Peptide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1117
- Specialty
- Clinical Chemistry
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|---|---|---|
| K093116 | Modification to: Ramp Influenza A/B AssayPSZ · Special | 10/21/2009SE |
| K091235 | Ramp RSV AssayGQG · Traditional | 07/24/2009SE |
| K071591 | Ramp Influenza A/B AssayPSZ · Traditional | 04/16/2008SE |
| K033747 | Ramp Ck-Mb AssayJHX · Traditional | 05/17/2004SE |
| K033745 | Ramp Troponin I AssayMMI · Traditional | 05/17/2004SE |
| K012040 | Ramp Myoglobin AssayDDR · Traditional | 12/18/2001SE |
Questions and answers
When was Ramp Nt-Probnp Assay cleared by the FDA?
Ramp Nt-Probnp Assay (K063662) received a 510(k) decision of Substantially Equivalent on July 21, 2008, 591 days after the submission was received.
What is the product code of K063662?
The FDA product code is NBC – Test, Natriuretic Peptide, a Class II (moderate risk) device regulated under 21 CFR 862.1117.