SYVA SOLID PHASE COLUMNS
FDA 510(k) clearance K844948 · decided 1985-08-29
Clearance details
- K-number
- K844948
- Device name
- SYVA SOLID PHASE COLUMNS
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1984-12-20
- Decision date
- 1985-08-29
- Days to decision
- 252 days
- Clearance type
- Traditional
- Product code
- KEA
- Device class
- 1
- Regulation number
- 862.2230
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC) (K890997) | Atlantic Wholesale, Inc. | 1989-03-28 |
| CM-TRISACRYL M DEAE-TRISACRYL M (K842028) | Lkb Instruments, Inc. | 1984-06-07 |
| AMBERLITE CG50 RESIN, 100-200 MESH (K833320) | Biosan Laboratories, Inc. | 1983-12-08 |
| BIO-REX 70 RESIN 100-200 MESH PH6.2 (K833319) | Biosan Laboratories, Inc. | 1983-11-03 |
| EXTRELUT QE EXTRACTION COLUMNS (K831027) | Emd Chemicals, Inc. | 1983-05-16 |
| I.E.C COLUMN (K830918) | Berwick Medical Products, Inc. | 1983-04-27 |
| EXETRELUT (K782066) | Mcb Manufacturing Chemists, Inc. | 1979-01-03 |
| EXTUBE (K781728) | Analytichem International, Inc. | 1978-12-20 |
Recalls involving this device
No recalls on record reference this clearance.