X-CAL
FDA 510(k) clearance K083200 · decided 2009-02-03
Clearance details
- K-number
- K083200
- Device name
- X-CAL
- Applicant
- Streck
- Decision
- Substantially Equivalent
- Date received
- 2008-10-30
- Decision date
- 2009-02-03
- Days to decision
- 96 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
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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 (K141962) | Streck | 2014-12-05 |
| 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 |
| 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.