AIA-PACK C-Peptide Control Set
FDA 510(k) clearance K143296 · decided 2014-12-16
Clearance details
- K-number
- K143296
- Device name
- AIA-PACK C-Peptide Control Set
- Applicant
- Tosoh Bioscience, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-11-17
- Decision date
- 2014-12-16
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- JJX
- Device class
- 1
- Regulation number
- 862.1660
- 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 |