ST AIA-PACK BNP Assay
FDA 510(k) clearance K211199 · decided 2021-11-08
Clearance details
- K-number
- K211199
- Device name
- ST AIA-PACK BNP Assay
- Applicant
- Tosoh Bioscience, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-04-22
- Decision date
- 2021-11-08
- Days to decision
- 200 days
- Clearance type
- Special
- Product code
- NBC
- Device class
- 2
- Regulation number
- 862.1117
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- South San Franciso, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AIA-PACK PSA (P910065/S009) | Tosoh Bioscience, Inc. | 2019-06-18 |
| IMMUNOASAY, PSA (P910065/S008) | Tosoh Bioscience, Inc. | 2012-02-13 |
| ST AIA-PACK PA (P910065/S007) | Tosoh Bioscience, Inc. | 2009-11-30 |
| AIA-PACK PA PSA, ST AIA-PACK PA PSA (P910065/S006) | Tosoh Bioscience, Inc. | 2005-11-30 |
| ST AIA-PACK PA (P910065/S005) | Tosoh Bioscience, Inc. | 2004-05-25 |
| ST AIA-PACK PA (P910065/S004) | Tosoh Bioscience, Inc. | 2003-08-12 |
| AIA-PACK PA (P910065/S003) | Tosoh Bioscience, Inc. | 2002-09-09 |
| AIA PACK PA (P910065/S002) | Tosoh Bioscience, Inc. | 2000-03-03 |