ST Aia-Pack C-Peptide II Calibrator Set
FDA 510(k) K140648 · Tosoh Bioscience, Inc.
510(k) numberK140648
Submission
- Device name
- ST Aia-Pack C-Peptide II Calibrator Set
- Applicant
- Tosoh Bioscience, Inc.
South San Franciso, CA, US - Received
- March 13, 2014
- Decision date
- April 10, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIT – Calibrator, Secondary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JIT
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|---|---|---|---|
| K171168 | VITROS Immunodiagnostic Products Insulin CalibratorsJIT · Abbreviated | Ortho Clinical Diagnostics | 05/16/2017SE |
| K170938 | CalSet IGF-1JIT · Traditional | Roche Diagnostics | 04/26/2017SE |
| K170160 | Abbott ARCHITECT Free T3JIT · Traditional | Abbott Laboratories | 02/15/2017SE |
| K163546 | Lumipulse G Progesterone-N CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/13/2017SE |
| K163534 | Lumipulse G FSH-N CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/13/2017SE |
| K163544 | Lumipulse G ProlactinJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/12/2017SE |
| K163521 | Lumipulse G LH CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/12/2017SE |
| K163078 | Dc-Uibc-CalJIT · Abbreviated | Sekisui Diagnostics P.E.I., Inc. | 12/08/2016SE |
| K163053 | Lumipulse G E2-III CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 12/01/2016SE |
| K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) CalibratorJIT · Special | Siemens Healthcare Diagnostics | 11/17/2016SE |
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| K211199 | ST AIA-PACK BNP AssayNBC · Special | 11/08/2021SE |
| K200904 | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8PDJ · Traditional | 08/05/2021SE |
| K160113 | ST AIA-PACK hsE2 Calibrator SetJIT · Traditional | 02/17/2016SE |
| K153417 | ST AIA-PACK PROG III Calibrator SetJIT · Traditional | 12/18/2015SE |
| K150270 | ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH…MRG · Traditional | 10/26/2015SE |
| K143075 | ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator SetCDZ · Traditional | 07/02/2015SE |
| K143296 | AIA-PACK C-Peptide Control SetJJX · Traditional | 12/16/2014SE |
| K143144 | ST AIA-PACK PROG II Calibrator SetJIT · Traditional | 12/03/2014SE |
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Questions and answers
When was ST Aia-Pack C-Peptide II Calibrator Set cleared by the FDA?
ST Aia-Pack C-Peptide II Calibrator Set (K140648) received a 510(k) decision of Substantially Equivalent on April 10, 2014, 28 days after the submission was received.
What is the product code of K140648?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.