Company
Beckman Coulter Mishima K.K.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
5recalls (1 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2026 | Beckman Coulter Mishima K.K. Systems/units containing affected software/SQL
BECKMAN COULTER CHEMISTRY ANALYZER AU480
REF / UDI-DI code:
B96692 / 14987666542965
B96693 / 14987666542972
B12183 / 14987666540671
The AU480 Chemistry Open, Classified |
JJE | K981743 |
| Jun 4, 2025 | Beckman Coulter Mishima K.K. Sample probe sucks a sample dispensed into a tube or cup and discharges the
appropriate amount into a cuvette.
Lot 178713114 - 179433670 Completed |
JJE | K961274 |
| Jun 4, 2025 | Beckman Coulter Mishima K.K. Sample probe sucks a sample dispensed into a tube or cup and discharges the
appropriate amount into a cuvette.
Lot 178713114 - 179433670 Completed |
CKB | K981743 |
| Aug 21, 2024 | Beckman Coulter Mishima K.K. DxC 500 AU Clinical Chemistry Analyzer, REF C63520
is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) ma Open, Classified |
JJE | K220977 |
| Jul 31, 2024 | Beckman Coulter Mishima K.K. DxC 500 AU Clinical Chemistry Analyzer, REF C63520
is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) ma Open, Classified |
JJE | K220977 |