← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
JPA — System, Multipurpose For In Vitro Coagulation Studies
DEVICE CLASS
Class II
REGULATION
21 CFR 864.5425
MEDICAL SPECIALTY
Hematology
REVIEW PANEL
HE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES
Recent clearances
K253658Diagnostica Stago, Inc. · 510k2026-04-27
K250965Sysmex America, Inc. · 510k2025-06-02
K251024Haemonetics · 510k2025-04-30
K243858Haemonetics Corporation · 510k2025-01-15
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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