FDA 510(k) Applications for Medical Device:
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K040181 | BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. W-110 | BREA | CA | 92822 |
| K955114 | DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
445 MEDICAL CENTER BLVD. | WEBSTER | TX | 77598 |
| K962895 | DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
445 MEDICAL CENTER BLVD. | WEBSTER | TX | 77598 |
| K973897 | KMI DIAGNOSTICS, INC. |
818 51ST AVE., N.E. | MINNEAPOLIS | MN | 55421 |
| K003174 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
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