FDA 510(k) Applications for Medical Device:
Control, Plasma, Abnormal
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K955040 | AMERICAN BIOPRODUCTS CO. |
5 CENTURY DR. | PARSIPPANY | NJ | 07054 |
| K020878 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618 |
| K023312 | DADE BEHRING, INC. |
514 GBC DR. | NEWARK | DE | 19702 |
| K061803 | DIAGNOSTICA STAGO, INC. |
5 CENTURY DR. | PARSIPPANY | NJ | 07054 |
| K993332 | GRADIPORE LTD. |
LOT16 RIVERSIDE CORPORATE PARK | NORTH RYDE | NSW 2113 | |
| K100103 | HELENA LABORATORIES |
1530 LINDBERGH DR. | BEAUMONT | TX | 77704 |
| K102552 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K012422 | KAMIYA BIOMEDICAL CO. |
910 INDUSTRY DR. | SEATTLE | WA | 98188-3412 |
| K961370 | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. |
6025 NICOLLE ST. | VENTURA | CA | 93003 |
| K984130 | PACIFIC HEMOSTASIS |
11515 VANSTORY DR. | HUNTERSVILLE | NC | 28078-8144 |
| K984131 | PACIFIC HEMOSTASIS |
11515 VANSTORY DR. | HUNTERSVILLE | NC | 28078-8144 |
| K032804 | PRECISION BIOLOGIC |
900 WINDMILL RD., SUITE 100 | DARTMOUTH, N.S. | B3B 1P7 | |
| K062306 | R2 DIAGNOSTICS, INC. |
1801 COMMERCE DR. | SOUTH BEND | IN | 46628 |
| K020109 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |
| K003329 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |
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