FDA 510(k) Applications for Medical Device:
Myoglobin, Antigen, Antiserum, Control
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K983848 | ABBOTT LABORATORIES |
200 ABBOTT PARK RD. | ABBOTT PARK, | IL | 60064-3537 |
| K962344 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K231832 | Beckman Coulter, Inc |
1000 Lake Hazeltine Drive | Chaska | MN | 55318 |
| K080481 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K000196 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K021229 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K983176 | BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K972513 | BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. | CONCORD | CA | 94524 |
| K974325 | CHIRON DIAGNOSTICS CORP. |
63 NORTH ST. | MEDFIELD | MA | 02052 |
| K984191 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K984065 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K981102 | DADE BEHRING, INC. |
PO BOX 6101 | NEWARK | DE | 19714-6101 |
| K965213 | DADE INTL., INC. |
2173 NW 99TH AVE. | MIAMI | FL | 33172 |
| K983970 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K991796 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K991277 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K123785 | DIAZYME LABORATORIES |
12889 GREGG COURT | POWAY | CA | 92064 |
| K042924 | FISHER DIAGNOSTICS |
8365 VALLEY PIKE, PO BX 307 | MIDDLETOWN | VA | 22645 |
| K042982 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K992976 | KAMIYA BIOMEDICAL CO. |
910 INDUSTRY DR. | SEATTLE | WA | 98188-3412 |
| K984145 | OLYMPUS DIAGNOSTICA GMBH |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747 |
| K033300 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K010700 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, CO. ANTRIM | BT29 4QY | |
| K012040 | RESPONSE BIOMEDICAL CORP. |
8855 NORTHBROOK COURT | BURNABY, BRITISH COLUMBIA | V5J 5J1 | |
| K083260 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250 |
| K061683 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K122599 | Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K982679 | SPECTRAL DIAGNOSTICS, INC. |
135-2 THE WEST MALL | TORONTO, ONTARIO | M9C1C2 | |
| K963680 | TEXAS IMMUNOLOGY, INC. |
5400 SPUR 248 | TYLER | TX | 75707 |
| K981012 | TOSOH MEDICS, INC. |
373 VINTAGE PARK DR. | FOSTER CITY | CA | 94404 |
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