FDA 510(k) Applications for Medical Device:
Colorimetry, Acetaminophen
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K020792 | BAYER DIAGNOSTICS CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K011465 | BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. W-110 | BREA | CA | 92822 |
| K000494 | BECKMAN COULTER, INC. |
200 S. KRAEMER BLVD.,M/S W-104 | BREA | CA | 92822-8000 |
| K043242 | BIOSITE INCORPORATED |
11030 ROSELLE ST. | SAN DIEGO | CA | 92121 |
| K061655 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY | NEWARK | DE | 19714-6101 |
| K002974 | DADE BEHRING, INC. |
3403 YERBA BUENA RD. | SAN JOSE | CA | 95161-9013 |
| K963244 | DADE INTL., INC. |
BUILDING 500, MAILBOX 514 | NEWARK | DE | 19714-6101 |
| K980031 | DIAGNOSTIC CHEMICALS LTD. |
WEST ROYALTY INDUSTRIAL PARK, | CHARLOTTETOWN, P.E.I. | C1E 2A6 | |
| K042330 | DIAGNOSTIC CHEMICALS LTD. |
16 MCCARVILLE ST. | CHARLOTTETOWN, PRINCE EDWARD | C1E 2A6 | |
| K981059 | DIAGNOSTIC CHEMICALS LTD. |
16 FIRST ST. | CHARLOTTETOWN, P.E.I. | C1E1B0 | |
| K961373 | DIAGNOSTIC REAGENTS, INC. |
601 CALIFORNIA AVE. | SUNNYVALE | CA | 94086 |
| K081938 | GENZYME DIAGNOSTICS P.E.I. INC. |
700 WATTS AVENUE | CHARLOTTETOWN, PRIN ED ISLAND | C1E 2B9 | |
| K110726 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K991598 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K013757 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K202644 | Sekisui Diagnostics P.E.I. INC. |
70 Watts Avenue | Charlottetown | C1E 2B9 | |
| K180835 | Sekisui Diagnostics PEI Inc. |
70 Watts Avenue | Charlottetown | C1E 2B9 | |
| K100200 | SIEMENS HEALTHCARE DIAGNOSTICS |
511 benedict Avenue | Tarrytown | NY | 10591 |
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