METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM
FDA 510(k) clearance K863840 · decided 1986-11-05
Clearance details
- K-number
- K863840
- Device name
- METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-10-01
- Decision date
- 1986-11-05
- Days to decision
- 35 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
No recalls on record reference this clearance.