Phospholipids Standard Solution Calibrator
FDA 510(k) K871765 · Wako Chemicals USA, Inc.
510(k) numberK871765
Submission
- Device name
- Phospholipids Standard Solution Calibrator
- Applicant
- Wako Chemicals USA, Inc.
Dallas, TX, US - Received
- May 5, 1987
- Decision date
- May 26, 1987
- 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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| K163053 | Lumipulse G E2-III CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 12/01/2016SE |
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| K053131 | Wako Total Bilirubin V, Models 410-22701, 998-23291, 416-22801, 990-23191JFM · Traditional | 12/30/2005SE |
| K042551 | Multi-Chem Calibrator aJIX · Traditional | 11/16/2004SE |
| K042550 | Multi-Lipid CalibratorJIX · Traditional | 11/08/2004SE |
| K042549 | Multi Chem Cal BJIX · Traditional | 11/08/2004SE |
Questions and answers
When was Phospholipids Standard Solution Calibrator cleared by the FDA?
Phospholipids Standard Solution Calibrator (K871765) received a 510(k) decision of Substantially Equivalent on May 26, 1987, 21 days after the submission was received.
What is the product code of K871765?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.