SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM
FDA 510(k) clearance K981973 · decided 1998-09-03
Clearance details
- K-number
- K981973
- Device name
- SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM
- Applicant
- Ram Scientific
- Decision
- Substantially Equivalent
- Date received
- 1998-06-05
- Decision date
- 1998-09-03
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- JKA
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SAFE-T-FILL Micro Capillary Blood Collection, 125 L Prepared with Dipotassium EDTA Purple, recall (Z-0372-2026) | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | 2025-10-27 |