BAYER RAPIDPOINT 405 SYSTEM
FDA 510(k) clearance K020616 · decided 2002-07-17
Clearance details
- K-number
- K020616
- Device name
- BAYER RAPIDPOINT 405 SYSTEM
- Applicant
- Bayer Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-02-25
- Decision date
- 2002-07-17
- Days to decision
- 142 days
- Clearance type
- Traditional
- Product code
- GKR
- Device class
- 2
- Regulation number
- 864.5620
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Medfield, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Bayer Diagnostics Corp.
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 |
|---|---|---|
| RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, 10696855, 1069 recall (Z-2479-2015) | Siemens Healthcare Diagnostics Inc | 2015-08-28 |
| Bayer Rapidpoint 405 Blood Gas Analyzer recall (Z-0066-04) | Bayer Corp. | 2003-10-24 |