Data / Medical devices / United States / MP Biomedicals Diagnostics Division
MP Biomedicals Diagnostics Division: FDA-registered device maker in Solon, OH, United States, 6 510(k) clearances
MP Biomedicals Diagnostics Division is registered with the FDA (registration 2419955) in Solon, OH, United States. It lists 7 device types. The FDA files 6 510(k) clearances under its listings, the newest dated April 18, 1984. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2419955
- Address
- 29525 Fountain Pkwy, Solon, OH, United States, 44139
- Owner or operator
- MP BIOMEDICALS LLC (9057708)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- May 30, 1995
- Registered through
- 2026
- Brand names listed
- 17OH-Progesterone DA, BE, E2) DOUBLE ANTIBODY, Estradiol DA, Free T4 Solid Phase RIA, Gastrin RIA kit, IMMUCHEM 17B-ESTRADIOL COATED TUBE, IMMUCHEM 17B-ESTRADIOL DOUBLE ANTIB and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Radioimmunoassay, Androstenedione | CIZ | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Estradiol | CHP | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Free Thyroxine | CEC | 2 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Gastrin | CGC | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Progesterone | JLS | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Total Estrogens, Nonpregnancy | JMD | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 18, 1984 | K840886 | HYDROXYPROGESTERONE BY RIA 17A | JLS | Substantially Equivalent | Radioassay Systems Laboratories, Inc. | accessdata.fda.gov |
| January 12, 1983 | K823264 | THYROXINE ANALYSIS PRODUCTS/RADIO-FREE | CEC | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| December 22, 1981 | K813484 | PROGESTERONE KIT BY RIA | JLS | Substantially Equivalent | Immuchem Corp. | accessdata.fda.gov |
| February 13, 1980 | K800126 | RSL (125 L) PROGESTERONE KIT | JLS | Substantially Equivalent | Radioassay Systems Laboratories, Inc. | accessdata.fda.gov |
| October 30, 1979 | K791999 | (125I) TESTOSTERONE KIT | CDZ | Substantially Equivalent | Radioassay Systems Laboratories, Inc. | accessdata.fda.gov |
| September 27, 1979 | K791652 | ESTRADIOL KIT BY RIA | CHP | Substantially Equivalent | Radioassay Systems Laboratories, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Radioimmunoassay, Estradiol
- All makers of Radioimmunoassay, Androstenedione
- All makers of Radioimmunoassay, Testosterones And Dihydrotestosterone
- All makers of Radioimmunoassay, Progesterone
- All makers of Radioimmunoassay, Gastrin
- All makers of Radioimmunoassay, Free Thyroxine
Updated April 18, 1984. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.