POINTCARE NOW SYSTEM
FDA 510(k) clearance K072869 · decided 2008-01-14
Clearance details
- K-number
- K072869
- Device name
- POINTCARE NOW SYSTEM
- Applicant
- Pointcare Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-10-09
- Decision date
- 2008-01-14
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- GKZ
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Marlborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PointCare NOW CD4NOW Gold Reagent Pack, or Gold Pack, Part Number :30034 In Vitro Diagnost recall (Z-1193-2012) | Pointcare Technologies, Inc. | 2012-03-08 |