STATSPIN STATSAMPLER
FDA 510(k) clearance K896206 · decided 1989-11-22
Clearance details
- K-number
- K896206
- Device name
- STATSPIN STATSAMPLER
- Applicant
- Statspin Technologies
- Decision
- Substantially Equivalent
- Date received
- 1989-10-26
- Decision date
- 1989-11-22
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- JKA
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Norwood, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| StatSampler 200 uL, Li Heparin (micro blood collector) Ref: SS2H Packed in Catalog Numbers recall (Z-2234-2008) | StatSpin, Inc., dba Iris Sample Processing | 2008-08-23 |