Syva Solid Phase Columns System II
FDA 510(k) K861392 · Syva Co.
510(k) numberK861392
Submission
- Device name
- Syva Solid Phase Columns System II
- Applicant
- Syva Co.
Palo Alto, CA, US - Received
- April 14, 1986
- Decision date
- June 13, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KZR – Chromatography (Liquid, Gel), Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2260
- Specialty
- Clinical Chemistry
Other 510(k)s with product code KZR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K973074 | 2487 Dual Wavelength Absorbance DetectorKZR · Traditional | Waters Corporation | 10/06/1997SE |
| K931227 | Usdt Flow Immunoassay System, Model 9000KZR · Traditional | U.S. Drug Testing, Inc. | 05/06/1993SE |
| K905538 | Columns Liquid Chromatography DPMKZR · Traditional | Millpore Corp. | 01/25/1991SE |
| K860197 | Series 410 LC PumpKZR · Traditional | The Perkin-Elmer Corp. | 03/17/1986SE |
| K851945 | Varian Aasp Automated Sample Prep. SystemKZR · Traditional | Varian Assoc., Inc. | 05/24/1985SE |
| K843568 | Liquid Chromatograph 400KZR · Traditional | The Perkin-Elmer Corp. | 11/20/1984SE |
| K841890 | Varian 2000 Liquid Chromatography AnalyKZR · Traditional | Varian Assoc., Inc. | 06/14/1984SE |
| K840977 | Liquid Chromatographic Detector LC-95KZR · Traditional | The Perkin-Elmer Corp. | 04/19/1984SE |
| K832201 | Chrom-PrepKZR · Traditional | Hamilton Co. | 08/16/1983SE |
| K802725 | Vista 54 Liquid Chromatography Anal. SysKZR · Traditional | Varian Assoc., Inc. | 12/11/1980SE |
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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 |
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Questions and answers
When was Syva Solid Phase Columns System II cleared by the FDA?
Syva Solid Phase Columns System II (K861392) received a 510(k) decision of Substantially Equivalent on June 13, 1986, 60 days after the submission was received.
What is the product code of K861392?
The FDA product code is KZR – Chromatography (Liquid, Gel), Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2260.