Sma Reference Serum 3
FDA 510(k) K770142 · Technicon Instruments Corp.
510(k) numberK770142
Submission
- Device name
- Sma Reference Serum 3
- Applicant
- Technicon Instruments Corp.
Mchenry, IL, US - Received
- January 24, 1977
- Decision date
- February 11, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIX – Calibrator, Multi-Analyte Mixture
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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| K141388 | System CalibraterJIX · Abbreviated | Beckman Coulter Ireland, Inc. | 07/11/2014SE |
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| K130765 | Elitech Clinical Systems Elical 2; Elitech Clinical Systems Elitrol I, Elitech Clinical…JIX · Abbreviated | Elitechgroup | 04/04/2013SE |
| K123321 | Dimension Chemistry III CalibratoryJIX · Traditional | Siemens Healthcare Diagnostics | 02/15/2013SE |
| K123372 | Abbott Lipid Multi Constituent CalibratorJIX · Traditional | Abbott Laboratories | 01/14/2013SE |
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| K912616 | Technicon Immuno 1 TM System Additional AnalytesKLI · Traditional | 09/25/1991SE |
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Questions and answers
When was Sma Reference Serum 3 cleared by the FDA?
Sma Reference Serum 3 (K770142) received a 510(k) decision of Substantially Equivalent on February 11, 1977, 18 days after the submission was received.
What is the product code of K770142?
The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.