CDS 3-PD HEMATOLOGY CONTROLS
FDA 510(k) clearance K024173 · decided 2003-01-14
Clearance details
- K-number
- K024173
- Device name
- CDS 3-PD HEMATOLOGY CONTROLS
- Applicant
- Clinical Diagnostic Solutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-12-18
- Decision date
- 2003-01-14
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- JPK
- Device class
- 2
- Regulation number
- 864.8625
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Plantation, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Clinical Diagnostic Solutions
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 CHECK BF (K160588) | Streck | 2016-12-22 |
| XN CHECK (K160590) | Streck | 2016-12-22 |
| XN-L CHECK (K160586) | Streck | 2016-12-22 |
| BC-5D Hematology Control (K160606) | R&D Systems, Inc. | 2016-09-01 |
| XN CHECK (K141964) | Streck | 2014-12-05 |
| XN CHECK BF (K141957) | Streck | 2014-12-05 |
| R&D 5D RETIC HEMATOLOGY CONTROL (K130962) | R&D Systems, Inc. | 2013-07-24 |
| XN CHECK BF (K120744) | Streck | 2012-10-19 |
| XN CHECK (K120742) | Streck | 2012-10-19 |
| R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL (K101578) | R&D Systems, Inc. | 2011-04-28 |
| COULTER LIN-X LINEARITY CONTROL, MODEL A81196 (K100790) | Beckman Coulter, Inc. | 2010-12-21 |
| COULTER 4C-EX 300 CELL CONTROL (K100607) | Beckman Coulter, Inc. | 2010-11-18 |