Syva Sample Seal
FDA 510(k) K844949 · Syva Co.
510(k) numberK844949
Submission
- Device name
- Syva Sample Seal
- Applicant
- Syva Co.
Palo Alto, CA, US - Received
- December 20, 1984
- Decision date
- February 15, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KIE – Apparatus, High Pressure Liquid Chromatography
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2260
- Specialty
- Clinical Chemistry
Other 510(k)s with product code KIE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K964588 | Waters 515 HPLC Pump (515)KIE · Traditional | Waters Corporation | 11/29/1996SE |
| K935666 | Perkin-Elmer Series 200 Liq Chromatographic PumpKIE · Traditional | The Perkin-Elmer Corp. | 04/26/1994SE |
| K924347 | Waters(Tm) 996 PdaKIE · Traditional | Millipore Corp. | 12/11/1992SE |
| K914841 | Chromatography Clinical Use 75JQRKIE · Traditional | Millipore Corp. | 12/10/1991SE |
| K911299 | Equipment/Material Decontaminating KitKIE · Traditional | Rohm and Haas Co. | 04/08/1991SE |
| K862506 | The Waters Model 990 Photodiode Array DetectorKIE · Traditional | Millipore Corp. | 07/29/1986SE |
| K844947 | Emit Ancillary ReagentsKIE · Traditional | Syva Co. | 06/28/1985SE |
| K800556 | Differential Refractive Index DetectorKIE · Traditional | Hewlett-Packard Co. | 03/25/1980SE |
| K800516 | Dupont Instruments Model 870 Liq. Chrom.KIE · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 03/19/1980SE |
| K800289 | LDC Spectromonitor IIIKIE · Traditional | Laboratory Data Control | 02/26/1980SE |
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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 |
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| 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 Syva Sample Seal cleared by the FDA?
Syva Sample Seal (K844949) received a 510(k) decision of Substantially Equivalent on February 15, 1985, 57 days after the submission was received.
What is the product code of K844949?
The FDA product code is KIE – Apparatus, High Pressure Liquid Chromatography, a Class I (low risk) device regulated under 21 CFR 862.2260.