Il 703, Stat Separator
FDA 510(k) K812750 · Instrumentation Laboratory CO
510(k) numberK812750
Submission
- Device name
- Il 703, Stat Separator
- Applicant
- Instrumentation Laboratory CO
Mchenry, IL, US - Received
- September 29, 1981
- Decision date
- January 26, 1982
- 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 |
| K813159 | Vacushield TMJRL · Traditional | Gelman Sciences, Inc. | 12/08/1981SE |
| K810829 | AcrodiscJRL · Traditional | Gelman Sciences, Inc. | 04/08/1981SE |
| K801500 | Ultrafree Calcium FilterJRL · Traditional | Millipore Corp. | 08/20/1980SE |
| 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 Il 703, Stat Separator cleared by the FDA?
Il 703, Stat Separator (K812750) received a 510(k) decision of Substantially Equivalent on January 26, 1982, 119 days after the submission was received.
What is the product code of K812750?
The FDA product code is JRL – Unit, Filter, Membrane, a Class I (low risk) device regulated under 21 CFR 862.2050.