Product code MTG ยท Class 3
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
0510(k)s in 12 months (0 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in MTG
| Company | 510(k)s | Recalls |
|---|---|---|
| Beckman Coulter Inc | 0 | 2 |
| Mckesson Medical-Surgical Inc. Corporate Office | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT. Open, Classified |
MTG | None listed |
| May 22, 2012 | Beckman Coulter Inc. Access Hybritech Free PSA, Part Number: 37210
Free PSA is used to aid in the differentiation between prostate cancer and benign prostatic conditions when total PSA levels are between 4 and 10 ng/mL. Terminated |
MTG | None listed |
| Sep 16, 2009 | Beckman Coulter Inc Beckman Coulter Access Hybritech free PSA Calibrators, REF 37215.
The Access Hybritech free PSA assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of fre Terminated |
MTG | None listed |
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