Emit Freelevel System I
FDA 510(k) K820224 · Syva Co.
510(k) numberK820224
Submission
- Device name
- Emit Freelevel System I
- Applicant
- Syva Co.
Mchenry, IL, US - Received
- January 27, 1982
- Decision date
- February 23, 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 |
| 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 |
| 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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| K993981 | Syva Emit II Plus Propoxyphene Assay, Models 9G029UL/9G129ULJXN · Traditional | 02/01/2000SE |
| K993980 | Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409ULDML · Traditional | 02/01/2000SE |
| K993988 | Syva Emit II Plus Cocaine Metabolite Assay, Model 9H029ULDIO · Traditional | 01/27/2000SE |
| K993987 | Syva Emit II Plus Barbiturate Assay, Model 9D029UL/9D129ULKLT · Traditional | 01/27/2000SE |
| K993986 | Syva Emit II Plus Methaqualone Assay, Model 9Q029UL/9Q129ULKXS · Traditional | 01/27/2000SE |
Questions and answers
When was Emit Freelevel System I cleared by the FDA?
Emit Freelevel System I (K820224) received a 510(k) decision of Substantially Equivalent on February 23, 1982, 27 days after the submission was received.
What is the product code of K820224?
The FDA product code is JRL – Unit, Filter, Membrane, a Class I (low risk) device regulated under 21 CFR 862.2050.