SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE
FDA 510(k) clearance K883181 · decided 1988-09-19
Clearance details
- K-number
- K883181
- Device name
- SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE
- Applicant
- Beckman Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-07-27
- Decision date
- 1988-09-19
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- CKA
- Device class
- 1
- Regulation number
- 862.1030
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Brea, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Beckman Instruments
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 |
|---|---|---|
| Synchron CX Immuno-Protein Cal, part number: 442840, other product code: CKA The Beckman C recall (Z-1229-2012) | Beckman Coulter Inc. | 2012-03-20 |
| GLU Reagent (GLU cartridge assay) used on Synchron LX and UniCel DxC Synchron Clinical Sys recall (Z-1619-2011) | Beckman Coulter Inc. | 2011-03-09 |