Ultrafree Calcium Filter
FDA 510(k) K801500 · Millipore Corp.
510(k) numberK801500
Submission
- Device name
- Ultrafree Calcium Filter
- Applicant
- Millipore Corp.
Mchenry, IL, US - Received
- June 27, 1980
- Decision date
- August 20, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JRL – Unit, Filter, Membrane
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2050
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JRL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K822121 | Acro PackJRL · Traditional | Gelman Sciences, Inc. | 08/05/1982SE |
| K820455 | Centrifree Micropartition SystemJRL · Traditional | Amicon, Inc. | 03/15/1982SE |
| K820224 | Emit Freelevel System IJRL · Traditional | Syva Co. | 02/23/1982SE |
| K812750 | Il 703, Stat SeparatorJRL · Traditional | Instrumentation Laboratory CO | 01/26/1982SE |
| K813159 | Vacushield TMJRL · Traditional | Gelman Sciences, Inc. | 12/08/1981SE |
| K810829 | AcrodiscJRL · Traditional | Gelman Sciences, Inc. | 04/08/1981SE |
| K790445 | Ultra-FreeJRL · Traditional | Millipore Corp. | 06/28/1979SE |
| K781043 | Cea-Immersible SeparatorJRL · Traditional | Millipore Corp. | 09/15/1978SE |
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Questions and answers
When was Ultrafree Calcium Filter cleared by the FDA?
Ultrafree Calcium Filter (K801500) received a 510(k) decision of Substantially Equivalent on August 20, 1980, 54 days after the submission was received.
What is the product code of K801500?
The FDA product code is JRL – Unit, Filter, Membrane, a Class I (low risk) device regulated under 21 CFR 862.2050.