P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR
FDA 510(k) clearance K961706 · decided 1996-07-31
Clearance details
- K-number
- K961706
- Device name
- P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR
- Applicant
- Fresenius USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-05-02
- Decision date
- 1996-07-31
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- LKN
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Walnut Creek, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Fresenius USA
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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 |
|---|---|---|
| The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator a recall (Z-2199-2011) | Fresenius Kabi, LLC | 2011-05-16 |