DIMENSION(TM) CLINICAL CHEMISTRY SYSTEM
FDA 510(k) clearance K860021 · decided 1986-02-11
Clearance details
- K-number
- K860021
- Device name
- DIMENSION(TM) CLINICAL CHEMISTRY SYSTEM
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-01-03
- Decision date
- 1986-02-11
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- JJE
- Device class
- 1
- Regulation number
- 862.2160
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Wilmington, DE, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch E.I. Dupont DE Nemours & Co.
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.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Dimension Calcium Flex Reagent is used on the Dimension clinical chemistry system as an in recall (Z-3039-2011) | Siemens Healthcare Diagnostics, Inc. | 2011-08-19 |