FDA 510(k) Applications for Medical Device:
Reagent, Russel Viper Venom
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K061805 | DIAGNOSTICA STAGO, INC. |
5 CENTURY DR. | PARSIPPANY | NJ | 07054 |
| K132076 | DSRV, INC. |
780 PARK NORTH BLVD. | Clarkston | GA | 30021 |
| K132130 | DSRV, INC. |
780 PARK NORTH BLVD. | Clarkston | GA | 30021 |
| K110031 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K990302 | INSTRUMENTATION LABORATORY CO. |
113 HARTWELL AVE. | LEXINGTON | MA | 02173 |
| K990579 | PRECISION BIOLOGIC |
900 WINDMILL RD., SUITE 100 | DARTMOUTH, N.S. | B3B 1P7 | |
| K990580 | PRECISION BIOLOGIC |
900 WINDMILL RD., SUITE 100 | DARTMOUTH, N.S. | B3B 1P7 | |
| K083878 | R2 DIAGNOSTICS, INC. |
1801 COMMERCE DR. | SOUTH BEND | IN | 46628 |
| K000528 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |
| K000527 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |
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