THEOPHYLLINE ASSAY TO THE CENTRIFICHEM
FDA 510(k) clearance K780441 · decided 1978-04-12
Clearance details
- K-number
- K780441
- Device name
- THEOPHYLLINE ASSAY TO THE CENTRIFICHEM
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1978-03-20
- Decision date
- 1978-04-12
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- LCY
- Device class
- 2
- Regulation number
- 862.3880
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| GDS ENZYMATIC THEOPHYLLINE REAGENT (K891761) | Gds Diagnostics | 1989-05-16 |
| THEOPHYLLINE ASSAY TO THE GEMSAEC (K780442) | Syva Co. | 1978-04-12 |
Recalls involving this device
No recalls on record reference this clearance.