SODIUM TEST KIT
FDA 510(k) clearance K832552 · decided 1983-09-20
Clearance details
- K-number
- K832552
- Device name
- SODIUM TEST KIT
- Applicant
- Mallinckrodt Critical Care
- Decision
- Substantially Equivalent
- Date received
- 1983-08-01
- Decision date
- 1983-09-20
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- CEI
- Device class
- 2
- Regulation number
- 862.1665
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Mallinckrodt Critical Care
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 (K914039) | Sterling Diagnostics, Inc. | 1991-10-31 |
| SODIUM REAGENT SET (K902572) | Tech Intl. Co. | 1990-07-10 |
Recalls involving this device
No recalls on record reference this clearance.