Atlas FDA

SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM

FDA 510(k) clearance K983517 · decided 1998-11-12

Clearance details

K-number
K983517
Device name
SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM
Applicant
Ram Scientific
Decision
Substantially Equivalent
Date received
1998-10-07
Decision date
1998-11-12
Days to decision
36 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

RecordFirmDate
SAFE-T-FILL Micro Capillary Blood Collection, 125 L; Prepared with Lithium Heparin; Green recall (Z-0544-2026)ASP Global, LLC. dba Anatomy Supply Partners, LLC.2025-11-19
SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Clot Activator and Seru recall (Z-0545-2026)ASP Global, LLC. dba Anatomy Supply Partners, LLC.2025-11-19
SAFE-T-FILL Micro Capillary Blood Collection, 300 L; Prepared with Clot Activator and Seru recall (Z-0546-2026)ASP Global, LLC. dba Anatomy Supply Partners, LLC.2025-11-19
SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Clot Activator; Red Mod recall (Z-0547-2026)ASP Global, LLC. dba Anatomy Supply Partners, LLC.2025-11-19
SAFE-T-FILL Micro Capillary Blood Collection, 300 L; Prepared with Clot Activator; Red Mod recall (Z-0548-2026)ASP Global, LLC. dba Anatomy Supply Partners, LLC.2025-11-19
AFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Lithium Heparin and Plas recall (Z-0549-2026)ASP Global, LLC. dba Anatomy Supply Partners, LLC.2025-11-19
SAFE-T-FILL Micro Capillary Blood Collection, 300 L; Prepared with Lithium Heparin and Pla recall (Z-0550-2026)ASP Global, LLC. dba Anatomy Supply Partners, LLC.2025-11-19
SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Lithium Heparin; Green recall (Z-0551-2026)ASP Global, LLC. dba Anatomy Supply Partners, LLC.2025-11-19
SAFE-T-FILL Micro Capillary Blood Collection, 300 L; Prepared with Lithium Heparin; Green recall (Z-0552-2026)ASP Global, LLC. dba Anatomy Supply Partners, LLC.2025-11-19
SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Sodium Fluoride; Gray M recall (Z-0553-2026)ASP Global, LLC. dba Anatomy Supply Partners, LLC.2025-11-19
SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Clot Activator; Amber M recall (Z-0554-2026)ASP Global, LLC. dba Anatomy Supply Partners, LLC.2025-11-19