FDA 510(k) Applications for Medical Device:
System, Fibrinogen Determination
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K965113 | CRESTAT DIAGNOSTICS, INC. |
374 GOODHILL RD. | WESTON | CT | 06883 |
| K050928 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY | NEWARK | DE | 19714-6101 |
| K251968 | Instrumentation Laboratory (IL) Co. |
180 Hartwell Rd | Bedford | MA | 01730 |
| K073367 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K970189 | PANBIO, INC. |
1539 N. IRONWOOD DR. | SOUTH BEND | IN | 46635 |
| K971858 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST.LOUIS | MO | 63103 |
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