Diamond Medica Ise Module Calibrant a Model ME-6370D, Diamond Medica Ise Module Calibrant B, Model ME-5410D
FDA 510(k) K093357 · Diamond Diagnostics, Inc.
510(k) numberK093357
Submission
- Device name
- Diamond Medica Ise Module Calibrant a Model ME-6370D, Diamond Medica Ise Module Calibrant B, Model ME-5410D
- Applicant
- Diamond Diagnostics, Inc.
Holliston, MA, US - Received
- October 28, 2009
- Decision date
- June 24, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
| 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 |
|---|---|---|
| K200544 | SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+CEM · Traditional | 10/01/2020SE |
| K133751 | Diamond Diagnostics Ise Serum Standards, Diamond Diagnostics Ise Urine StandardsJIT · Traditional | 08/08/2014SE |
| K124009 | Mission Clinicheck Assayed Chemistry Controls, Level 1, Mission Clinicheck Assayed…JJY · Traditional | 04/17/2013SE |
| K121027 | Diamond Calibrator Low, Diamond Calibrator HighJIT · Traditional | 12/20/2012SE |
| K121040 | Smartlyte Electrolyte AnalyzerCEM · Traditional | 08/30/2012SE |
| K121140 | Prolyte Electrolyte AnalyzerJGS · Traditional | 08/22/2012SE |
| K120591 | Diamond Tokyo Boeki Ise Module Calibrator 1,2,1-2JIT · Traditional | 04/17/2012SE |
| K103364 | Mission Clinicheck Assayed Chemistry Controls, Level 1, Level 2, Dual LevelJJY · Traditional | 05/06/2011SE |
| K102959 | Prolyte Electrolyte AnalyzerJGS · Traditional | 01/14/2011SE |
| K093492 | Mission Clinicheck Assayed Chemistry Control, Level 1&2, Mission Clinical CalibratorJJY · Traditional | 03/19/2010SE |
Questions and answers
When was Diamond Medica Ise Module Calibrant a Model ME-6370D, Diamond Medica Ise Module Calibrant B, Model ME-5410D cleared by the FDA?
Diamond Medica Ise Module Calibrant a Model ME-6370D, Diamond Medica Ise Module Calibrant B, Model ME-5410D (K093357) received a 510(k) decision of Substantially Equivalent on June 24, 2010, 239 days after the submission was received.
What is the product code of K093357?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.