XN CAL
FDA 510(k) clearance K141962 · decided 2014-12-05
Clearance details
- K-number
- K141962
- Device name
- XN CAL
- Applicant
- Streck
- Decision
- Substantially Equivalent
- Date received
- 2014-07-18
- Decision date
- 2014-12-05
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- KRX
- Device class
- 2
- Regulation number
- 864.8150
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- La Vista, NE, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Streck
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 |
|---|---|---|
| XN CAL (K160585) | Streck | 2016-12-22 |
| XN CAL PF (K141955) | Streck | 2014-12-05 |
| XN CAL PF (K120747) | Streck | 2012-10-22 |
| XN CAL (K120745) | Streck | 2012-10-19 |
| CELL-DYN 22 PLUS CALIBRATOR (K111204) | Streck | 2011-12-22 |
| X-CAL (K083200) | Streck | 2009-02-03 |
| CAL-CHEX CD PLUS (K020469) | Streck Laboratories, Inc. | 2002-04-04 |
| CD-CAL PLUS CALIBRATOR (K003991) | R&D Systems, Inc. | 2001-01-16 |
| CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER (K993375) | Clinical Diagnostic Solutions, Inc. | 1999-12-20 |
| CBC-CAL PLUS HEMATOLOGY CALIBRATOR (K955925) | R&D Systems, Inc. | 1996-02-29 |
| 3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE (K912357) | R&D Systems, Inc. | 1991-07-09 |
| CBC-CAL (TM) PLUS/MULTIPLE (K862858) | R&D Systems, Inc. | 1986-08-21 |
Recalls involving this device
No recalls on record reference this clearance.