FDA 510(k) Applications for Medical Device:
Drug Mixture Control Materials
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K971534 | BECKMAN |
200 SOUTH KRAEMER BLVD. | BREA | CA | 92621 |
| K983709 | BECKMAN COULTER, INC. |
200 S. KRAEMER BLVD.,M/S W-104 | BREA | CA | 92822-8000 |
| K972819 | BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD., W-337 | BREA | CA | 92622-8000 |
| K970666 | BIO-RAD |
3726 EAST MIRALOMA AVE. | ANAHEIM | CA | 92806 |
| K033366 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618 |
| K052053 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K012741 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K971691 | BIO-RAD |
3726 EAST MIRALOMA AVE. | ANAHEIM | CA | 92806 |
| K033404 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618 |
| K981590 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618 |
| K021415 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K021414 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K021411 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K022707 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618 |
| K021384 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K042865 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K041561 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K955153 | BIO-RAD |
3726 EAST MIRALOMA AVE. | ANAHEIM | CA | 92806 |
| K972174 | BIO-RAD |
3726 EAST MIRALOMA AVE. | ANAHEIM | CA | 92806 |
| K980871 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K093577 | Bio-Rad Laboratories |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K121143 | Bio-Rad Laboratories |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K050682 | BIO-RAD LABORATORIES, INC. |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K033924 | BIO-RAD LABORATORIES, INC. |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K120504 | BIO-RAD LABORATORIES, INC. |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K072721 | BIO-RAD, DIAGNOSTICS GRP. |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K121122 | BIOCHEMICAL DIAGNOSTIC, INC. |
180 HEARTLAND BLVD. | Edgewood | NY | 11717 |
| K153474 | BIOCHEMICAL DIAGNOSTICS, INC |
180 HEARTLAND BLVD | EDGEWOOD | NY | 11717 |
| K132688 | BIOCHEMICAL DIAGNOSTICS, INC. |
180 HEARTLAND BLVD. | Edgewood | NY | 11717 |
| K063398 | BIONOSTICS, INC. |
7 JACKSON RD. | DEVENS | MA | 01434 |
| K013002 | BIOSITE INCORPORATED |
11030 ROSELLE ST. | SAN DIEGO | CA | 92121 |
| K060788 | BIOSITE INCORPORATED |
9975 SUMMERS RIDGE RD | SAN DIEGO | CA | 92121 |
| K050037 | BIOSITE INCORPORATED |
11030 ROSELLE ST. | SAN DIEGO | CA | 92121 |
| K012999 | BIOSITE INCORPORATED |
11030 ROSELLE ST. | SAN DIEGO | CA | 92121 |
| K965157 | BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. | CONCORD | CA | 94524-4117 |
| K971060 | BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. | CONCORD | CA | 94524-4117 |
| K960244 | CASCO STANDARDS |
P.O. BOX 970 | YARMOUTH | ME | 04096-1970 |
| K012907 | CLINICAL CONTROLS |
12038 CENTRALIA RD. | HAWAIIAN GARDENS | CA | 90716 |
| K062191 | DADE BEHRING, INC. |
500 GBC DR., M/S 514 | NEWARK | DE | 19714 |
| K041666 | DIAGNOSTIC CHEMICALS LTD. |
16 MCCARVILLE ST. | CHARLOTTETOWN, PRINCE EDWARD | C1E 2A6 | |
| K964771 | DYNA-TEK INDUSTRIES |
8971 HALL DR. | LENEXA | KS | 66219 |
| K971058 | MEDICAL ANALYSIS SYSTEMS, INC. |
542 FLYNN RD. | CAMARILLO | CA | 93012-8058 |
| K032826 | MEDICAL ANALYSIS SYSTEMS, INC. |
5300 ADOLFO RD. | CAMARILLO | CA | 93012 |
| K982024 | MEDICAL ANALYSIS SYSTEMS, INC. |
542 FLYNN RD. | CAMARILLO | CA | 93012-8058 |
| K983127 | MEDICAL ANALYSIS SYSTEMS, INC. |
LINCOLN TECHNOLOGY PARK | CAMARILLO | CA | 93012 |
| K961724 | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. |
6025 NICOLLE ST. | VENTURA | CA | 93003 |
| K040758 | MICROGENICS CORP. |
46360 FREMONT BLVD. | FREMONT | CA | 94538 |
| K103656 | Microgenics Corporation |
46360 FREMONT BLVD. | FREMONT | CA | 94538 |
| K980331 | MORE DIAGNOSTICS |
2020 11TH ST. | LOS OSOS | CA | 93402 |
| K982649 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K060417 | QUANTIMETRIX CORP. |
2005 MANHATTAN BEACH BLVD. | REDONDO BEACH | CA | 90278-1205 |
| K012319 | RANDOX LABORATORIES, LTD. |
ARDMORE, DIAMOND ROAD | CRUMLIN, CO. ANTRIM | BT29 4QY | |
| K962165 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
1080 U.S. HIGHWAY 202 | BRANCHBURG | NJ | 08876-3771 |
| K983387 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
BRANCHBURG TOWNSHIP | SOMERVILLE | NJ | 08876-3771 |
| K964422 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
BRANCHBURG TOWNSHIP | SOMERVILLE | NJ | 08876-3771 |
| K080183 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. BX 50416 | INDIANAPOLIS | IN | 46250-0416 |
| K990377 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K982217 | SC CALIBRATORS & CONTROLS LLC. |
1701 BERKELEY ST. | SANTA MONICA | CA | 90404 |
| K992395 | SERACARE TECHNOLOGY |
2170 WOODWARD ST. | AUSTIN | TX | 78744-1832 |
| K132174 | TECHNO-PATH MANUFACTURING LTD. |
325 BIG ELM ST. | HIGHLAND VILLAGE | TX | 75077 |
| K080085 | Thermo Fisher Scientific |
46360 FREMONT BLVD. | FREMONT | CA | 94538 |
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