SODIUM REAGENT SET
FDA 510(k) clearance K914039 · decided 1991-10-31
Clearance details
- K-number
- K914039
- Device name
- SODIUM REAGENT SET
- Applicant
- Sterling Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-09-10
- Decision date
- 1991-10-31
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- CEI
- Device class
- 2
- Regulation number
- 862.1665
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Sterling Heights, MI, 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 |
|---|---|---|
| SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2 (K043268) | Randox Laboratories, Ltd. | 2005-02-15 |
| SODIUM REAGENT SET (K902572) | Tech Intl. Co. | 1990-07-10 |
| SODIUM TEST KIT (K832552) | Mallinckrodt Critical Care | 1983-09-20 |
Recalls involving this device
No recalls on record reference this clearance.