FDA 510(k) Applications for Medical Device:
Calibrator, Dose, Radionuclide
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K090296 | BIODEX MEDICAL SYSTEMS, INC. |
20 RAMSAY RD. | SHIRLEY | NY | 11967 |
| K101452 | CAPINTEC, INC. |
620 ALPHA DR. | PITTSBURGH | PA | 15238 |
| K071396 | CAPINTEC, INC. |
620 ALPHA DR. | PITTSBURGH | PA | 15241 |
| K192199 | Capintec, Inc. |
7 Vreeland Road | Florham Park | NJ | 07932 |
| K141413 | CAPINTEC, INC. |
620 ALPHA DR. | PITTSBURGH | PA | 15241 |
| K020150 | CAPINTEC, INC. |
540 ALPHA DR. | PITTSBURGH | PA | 15238 |
| K162394 | Capintec, Inc. |
7 Vreeland Road | Florham Park | NJ | 07932 |
| K142325 | Comecer Netherlands b.v. |
Madam Curieweg 1 | Joure | 8501 XC | |
| K042746 | COMECER S.R.L. |
PO BOX 4341 | CROFTON | MD | 21114 |
| K011493 | MENTOR CORP. |
9727 VALLEY VIEW RD. | EDEN PRAIRIE | MN | 55344 |
| K010417 | NUCLEAR ASSOC., DIV. INOVISION LP |
100 VOICE RD. | CARLE PLACE | NY | 11514 |
| K030066 | NUCLEAR ASSOCIATES |
120 ANDREWS RD. | HICKSVILLE | NY | 11801 |
| K002833 | STANDARD IMAGING, INC. |
7601 MURPHY DR. | MIDDLETON | WI | 53562-2766 |
| K013548 | STANDARD IMAGING, INC. |
7601 MURPHY DR. | MIDDLETON | WI | 53562-2766 |
| K013689 | SUN NUCLEAR CORP. |
425-A PINEDA COURT | MELBOURNE | FL | 32940 |
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