Fisher Diagnostics Sera Chem Smac Calibrators
FDA 510(k) K844047 · Fisher Diagnostics
510(k) numberK844047
Submission
- Device name
- Fisher Diagnostics Sera Chem Smac Calibrators
- Applicant
- Fisher Diagnostics
Orangeburg, NY, US - Received
- October 17, 1984
- Decision date
- November 9, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Siemens Healthcare Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K170652 | ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S…PRI · Traditional | 06/01/2017SE |
| K070640 | Architect Stat TROPONIN-1; MyoglobinMMI · Special | 09/13/2007SE |
| K052407 | Architect Anti-Tpo Immunoassay, Calibrators & ControlsJZO · Traditional | 07/18/2006SE |
| K052308 | Architect Anti-Tg Immunoassay Reagents, Calibrators, Controls and System Assay Cd-RomJZO · Traditional | 05/10/2006SE |
| K042924 | Architect Stat Myo ImmunoassayDDR · Traditional | 01/24/2005SE |
| K041192 | Architect Stat Troponin-I ImmunoassayMMI · Traditional | 08/12/2004SE |
| K041596 | Architect Stat Ck-Mb ImmunoassayJHX · Traditional | 07/21/2004SE |
| K023362 | Fisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen Reagent Plus KaolinGKP · Traditional | 12/09/2002SE |
| K013397 | Pacific Hemostasis Reference EmulsionJIX · Traditional | 02/15/2002SE |
| K010750 | Pacific Hemostasis Inr Control Plasmas, Model Catalog 100560GGN · Traditional | 09/07/2001SE |
Questions and answers
When was Fisher Diagnostics Sera Chem Smac Calibrators cleared by the FDA?
Fisher Diagnostics Sera Chem Smac Calibrators (K844047) received a 510(k) decision of Substantially Equivalent on November 9, 1984, 23 days after the submission was received.
What is the product code of K844047?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.