CERULOPLASMIN FOR THE TECHNICON DPA-1(TM) SYSTEM
FDA 510(k) clearance K882622 · decided 1988-07-08
Clearance details
- K-number
- K882622
- Device name
- CERULOPLASMIN FOR THE TECHNICON DPA-1(TM) SYSTEM
- Applicant
- Technicon Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 1988-06-24
- Decision date
- 1988-07-08
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- JFR
- Device class
- 2
- Regulation number
- 866.5210
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Tarrytown, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Technicon Instruments Corp.
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 |
|---|---|---|
| SENTINEL CERULOPLASMIN (K051456) | Sentinel Ch. Srl | 2005-10-21 |
Recalls involving this device
No recalls on record reference this clearance.