Lumipulse G FSH-N Calibrators
FDA 510(k) K163534 · Fujirebio Diagnostics,Inc.
510(k) numberK163534
Submission
- Device name
- Lumipulse G FSH-N Calibrators
- Applicant
- Fujirebio Diagnostics,Inc.
Malvern, PA, US - Received
- December 16, 2016
- Decision date
- January 13, 2017
- 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
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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 |
| 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 |
| K160113 | ST AIA-PACK hsE2 Calibrator SetJIT · Traditional | Tosoh Bioscience, Inc. | 02/17/2016SE |
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| K172713 | Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS PCT…PRI · Traditional | 12/10/2017SE |
| K171103 | Lumipulse G TSH-III Immunoreaction CartridgesJLW · Traditional | 07/28/2017SE |
| K163546 | Lumipulse G Progesterone-N CalibratorsJIT · Abbreviated | 01/13/2017SE |
| K163544 | Lumipulse G ProlactinJIT · Abbreviated | 01/12/2017SE |
Questions and answers
When was Lumipulse G FSH-N Calibrators cleared by the FDA?
Lumipulse G FSH-N Calibrators (K163534) received a 510(k) decision of Substantially Equivalent on January 13, 2017, 28 days after the submission was received.
What is the product code of K163534?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.