FDA 510(k) Applications for Medical Device:
Platelet Factor 4 Radioimmunoassay
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K040293 | AKERS LABORATORIES, INC. |
201 GROVE RD. | THOROFARE | NJ | 08086 |
| K003767 | DIAGNOSTICA STAGO, INC. |
FIVE CENTURY DR. | PARSIPPANY | NJ | 07054 |
| K983379 | GENETIC TESTING INSTITUTE |
150 NORTH PATRICK BLVD. | BROOKFIELD | WI | 53045-5854 |
| K053559 | GENETIC TESTING INSTITUTE |
20925 CROSSROADS CIRCLE | WAUKESHA | WI | 53186-4054 |
| K071781 | GENETIC TESTING INSTITUTE |
20925 CROSSROADS CIRCLE | WAUKESHA | WI | 53186-4054 |
| K071255 | HYPHEN BIOMED |
6560 GOVE COURT | MASON | OH | 45040 |
| K201570 | Immucor GTI Diagnostics, Inc. |
20925 Crossroads Circle | Waukesha | WI | 53186 |
| K201311 | Immucor GTI Diagnostics, Inc. |
20925 Crossroads Circle | Waukesha | WI | 53185 |
| K243374 | Instrumentation Laboratory (IL) Co. |
180 Hartwell Rd | Bedford | MA | 01730 |
| K170854 | Instrumentation Laboratory Co. |
180 Hartwell Road | Bedford | MA | 01730 |
| K153137 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL Road | BEDFORD | MA | 01730 |
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