Panels › Clinical Chemistry › Product code CKB · Class 2
Acid Phosphatase, Naphthyl Phosphate
Regulation 862.1020
0510(k)s in 12 months (24 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in CKB
| Company | 510(k)s | Recalls |
|---|---|---|
| Data Medical Associates, Inc. | 2 | 0 |
| Olympus America, Inc. | 2 | 0 |
| Abbott Diagnostics Mfg., Inc. | 1 | 0 |
| American Dade | 1 | 0 |
| Bayer Diagnostics Corp. | 1 | 0 |
| Beckman Coulter, Inc. | 1 | 0 |
| Beckman Coulter Mishima K.K. | 0 | 1 |
| Boehringer Mannheim Corp. | 1 | 0 |
| Cooper Biomedical, Inc. | 1 | 0 |
| Crestat Diagnostics, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products AcP Slides, 90 slides/pack; catalog number 8168122
VITROS Chemistry Products AcP Slides quantitatively measure acid phosphatase (AcP) activity in serum and plasma using VITRO Terminated |
CKB | None listed |
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