FDA 510(k) Applications for Medical Device:
Radioimmunoassay, Follicle-Stimulating Hormone
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K041165 | ACON LABORATORIES, INC. |
163 CABOT ST. | BEVERLY | MA | 01915 |
| K964693 | BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. | CONCORD | CA | 94524 |
| K962118 | DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
445 MEDICAL CENTER BLVD. | WEBSTER | TX | 77598 |
| K030058 | EARLY DETECT, INC. |
2950 NORTH GLASSELL ST. | ORANGE | CA | 92865 |
| K002450 | GENUA 1944, INC. |
53 CEDAR LAKE RD. | BLAIRSTOWN | NJ | 07825 |
| K052662 | IND DIAGNOSTIC INC. |
1629 FOSTERS WAY | DELTA, B.C. | V3M 6S7 | |
| K964720 | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14650-0882 |
| K972720 | MONOBIND |
729 WEST 16TH ST., C-4 | COSTA MESA | CA | 92627 |
| K043599 | PHAMATECH INC. |
10151 BARNES CANYON RD | SAN DIEGO | CA | 92121 |
| K040575 | PHAMATECH INC. |
10151 BARNES CANYON ROAD | SAN DIEGO | CA | 92121 |
| K970085 | SEALITE SCIENCES, INC. |
3000 NORTHWOODS PKWY. | NORCROSS | GA | 30071 |
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