Osmometer Standard Solutions
FDA 510(k) K892329 · D.R.G. Scientific Industries
510(k) numberK892329
Submission
- Device name
- Osmometer Standard Solutions
- Applicant
- D.R.G. Scientific Industries
East Boston, MA, US - Received
- April 5, 1989
- Decision date
- October 31, 1989
- 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
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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 |
More from Siemens Healthcare Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K870889 | Acid Fuchsin SolutionsFKQ · Traditional | 07/08/1987SE |
| K863880 | Blood Gases/ PO2, PCO2 and Blood PH Analysis Prod.CHL · Traditional | 11/24/1986SE |
| K863825 | Co-Oximeter SolutionsJKS · Traditional | 11/24/1986SE |
| K863824 | Solution/Test Standard/Conduct. Dialy.&Mult.Solut.FKH · Traditional | 10/24/1986SE |
Questions and answers
When was Osmometer Standard Solutions cleared by the FDA?
Osmometer Standard Solutions (K892329) received a 510(k) decision of Substantially Equivalent on October 31, 1989, 209 days after the submission was received.
What is the product code of K892329?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.