Module 486 Variable Wavelength Tunable Uv/Vis Dete
FDA 510(k) K903647 · Millipore Corp.
510(k) numberK903647
Submission
- Device name
- Module 486 Variable Wavelength Tunable Uv/Vis Dete
- Applicant
- Millipore Corp.
Milford, MA, US - Received
- August 9, 1990
- Decision date
- September 11, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LDM – Instrumentation, High Pressure Liquid Chromatography
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2260
- Specialty
- Clinical Chemistry
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| K872582 | High Pressure Liquid Chromatography SystemLDM · Traditional | Millipore Corp. | 07/16/1987SE |
| K870949 | Waters 650 Advanced Protein Purification SystemLDM · Traditional | Millipore Corp. | 04/22/1987SE |
| K862178 | Isopure LC SystemLDM · Traditional | The Perkin-Elmer Corp. | 07/14/1986SE |
| K850272 | Waters 740 Data Module-Plotter IntegratorLDM · Traditional | Millipore Corp. | 03/06/1985SE |
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| K924347 | Waters(Tm) 996 PdaKIE · Traditional | 12/11/1992SE |
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Questions and answers
When was Module 486 Variable Wavelength Tunable Uv/Vis Dete cleared by the FDA?
Module 486 Variable Wavelength Tunable Uv/Vis Dete (K903647) received a 510(k) decision of Substantially Equivalent on September 11, 1990, 33 days after the submission was received.
What is the product code of K903647?
The FDA product code is LDM – Instrumentation, High Pressure Liquid Chromatography, a Class I (low risk) device regulated under 21 CFR 862.2260.