FERR FLEX REAGENT CARTRIDGE
FDA 510(k) clearance K963498 · decided 1997-01-24
Clearance details
- K-number
- K963498
- Device name
- FERR FLEX REAGENT CARTRIDGE
- Applicant
- Dade Chemistry Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-09-03
- Decision date
- 1997-01-24
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- JMG
- Device class
- 2
- Regulation number
- 866.5340
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used recall (Z-2238-2014) | Siemens Healthcare Diagnostics, Inc. | 2014-08-15 |
| Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: recall (Z-0561-2014) | Siemens Healthcare Diagnostics, Inc. | 2013-12-24 |