510(k) K844948
- Device
- Syva Solid Phase Columns
- Applicant
- SYVA CO.
- 510(k) number
- K844948
- Product code
- KEA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-08-29
- Date received
- 1984-12-20
- Regulation
- 862.2230
- Classification name
- Resins, Ion-Exchange
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOAN KURJIAN
- Address
- 900 Arastradero Rd. P.O. Box 10058 Palo Alto CA US 94303 94303
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KEA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K890997 | ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC) | Atlantic Wholesale, Inc. | 1989-03-28 |
| K842028 | CM-TRISACRYL M DEAE-TRISACRYL M | Lkb Instruments, Inc. | 1984-06-07 |
| K833320 | AMBERLITE CG50 RESIN, 100-200 MESH | Biosan Laboratories, Inc. | 1983-12-08 |
| K833319 | BIO-REX 70 RESIN 100-200 MESH PH6.2 | Biosan Laboratories, Inc. | 1983-11-03 |
| K831027 | EXTRELUT QE EXTRACTION COLUMNS | Emd Chemicals, Inc. | 1983-05-16 |
| K830918 | I.E.C COLUMN | Berwick Medical Products, Inc. | 1983-04-27 |
| K782066 | EXETRELUT | Mcb Manufacturing Chemists, Inc. | 1979-01-03 |
| K781728 | EXTUBE | Analytichem International, Inc. | 1978-12-20 |