510(k) K082645
- Device
- DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623
- Applicant
- SIEMENS HEALTHCARE DIAGNOSTICS
- 510(k) number
- K082645
- Product code
- NBC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-09-22
- Date received
- 2008-09-11
- Regulation
- 862.1117
- Classification name
- Test, Natriuretic Peptide
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- VICTOR M CARRIO
- Address
- Ms 514, P.O. Box 6101 Newark DE US 19714 19714
FDA Registration Numbers#
- 3013982035
- 3006198300
- 2246703
- 3005360469
- 3014353045
- 3005174594
- 3005333358
- 2432235
- 3012963943
- 2250051
- 3004205692
- 3002809144
- 9612316
- 8032314
- 2517506
- 2521625
- 2122870
- 8031673
- 3005643513
- 3011989923
- 2032682
- 3002637618
- 9610987
- 2245578
- 3002642396
- 3010825766
- 3029973107
- 8020888
- 1219913
- 3005529799
- 3007111389
- 9610126
- 1319681
- 2435505
- 3000308930
- 2032839
- 3004192065
Source Documents#
Other 510(k) Records For Product Code NBC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252169 | Access BNP II | Beckman Coulter, Inc. | 2026-03-24 |
| K253539 | Alere NT-proBNP for Alinity i | Axis-Shield Diagnostics, Ltd. | 2026-02-18 |
| K241176 | Alere NT-proBNP for Alinity i Reagent Kit | Axis-Shield Diagnostics, Ltd. | 2025-01-16 |
| K232164 | Access NT-proBNP | Beckman Coulter, Inc. | 2024-04-12 |
| K220265 | ADVIA Centaur® NT-proBNPII (PBNPII) | Siemens Healthcare Diagnostics, Inc. | 2023-09-24 |
| K223637 | Elecsys proBNP II, Elecsys proBNP II STAT | Roche Diagnostics | 2023-07-21 |
| K210546 | Elecsys proBNP II, Elecsys proBNP II STAT | Roche Diagnostics | 2022-03-31 |
| K211199 | ST AIA-PACK BNP Assay | Tosoh Bioscience, Inc. | 2021-11-08 |
| K201312 | VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack | Ortho Clinical Diagnostics | 2021-10-04 |
| K192380 | ST AIA-PACK BNP | Fujirebio Diagnostics,Inc. | 2020-08-24 |
| K092649 | ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190 | Roche Diagnostics Corp. | 2010-02-04 |
| K063662 | RAMP NT-PROBNP ASSAY | Response Biomedical Corp. | 2008-07-21 |
| K080269 | TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS | Biosite Incorporated | 2008-06-06 |
| K080578 | DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA | Siemens Healthcare Diagnostics, Inc. | 2008-05-16 |
| K073091 | VIDAS NT-PROBNP ASSAY, MODEL: 30 449 | bioMerieux, Inc. | 2008-02-29 |
Legacy Summary#
summary
FDA Review#
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