CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY
FDA 510(k) clearance K874824 · decided 1988-01-21
Clearance details
- K-number
- K874824
- Device name
- CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY
- Applicant
- Supelco, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-11-24
- Decision date
- 1988-01-21
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- DII
- Device class
- 1
- Regulation number
- 862.2250
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Bellefonte, PA, 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 |
|---|---|---|
| CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY (K862542) | Supelco, Inc. | 1986-08-04 |
| REACTIFS, IBF ULTROGELS ACA & ULTROGELS A (K844164) | Lkb Instruments, Inc. | 1984-12-10 |
| CAPILLARY GAS CHROMATOGRAPHIC COLUMNS (K841712) | Supelco, Inc. | 1984-05-21 |
| 19091-XXXXX SER. OF GLASS CAPILLARY COL. (K791893) | Hewlett-Packard Co. | 1979-10-30 |
Recalls involving this device
No recalls on record reference this clearance.