FDA 510(k) Applications for Medical Device:
Calibrators, Drug Specific
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K993473 | BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. W-110 | BREA | CA | 92822 |
| K993022 | BECKMAN COULTER, INC. |
200 S. KRAEMER BLVD.,M/S W-104 | BREA | CA | 92822-8000 |
| K972433 | BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. | CONCORD | CA | 94524 |
| K011112 | DADE BEHRING, INC. |
P.O. BOX 6101 BUILDING 500 | NEWARK, | DE | 19714 |
| K053108 | DADE BEHRING, INC. |
P.O. BOX 6101, M/S 514 | NEWARK | DE | 19702 |
| K061503 | DADE BEHRING, INC. |
P.O. BOX 6101 MS 514 | NEWARK | DE | 19714-6101 |
| K052015 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K060503 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K062199 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714 |
| K062182 | DADE BEHRING, INC. |
500 GBC DR., M/S 514 | NEWARK | DE | 19714 |
| K020845 | DADE BEHRING, INC. |
514 GBC DR. | NEWARK | DE | 19702 |
| K972835 | DIAGNOSTIC REAGENTS, INC. |
601 CALIFORNIA AVE. | SUNNYVALE | CA | 94086 |
| K981926 | EMD CHEMICALS INC. |
480 DEMOCRAT RD. | GIBBSTOWN | NJ | 08027 |
| K033601 | LABONE, INC. |
10101 RENNER BLVD. | LENEXA | KS | 66219 |
| K021449 | Lin-Zhi International, Inc. |
2391 ZANKER RD., SUITE 340 | SAN JOSE | CA | 95131-1124 |
| K020769 | Lin-Zhi International, Inc. |
2391 ZANKER RD., SUITE 340 | SAN JOSE | CA | 95131-1124 |
| K023316 | Lin-Zhi International, Inc. |
687 NORTH PASTORIA AVE. | SYNNYVALE | CA | 94085-2917 |
| K955813 | MICROGENICS CORP. |
2380 A BISSO LN. | CONCORD | CA | 94520 |
| K012109 | MICROGENICS CORP. |
46360 FREMONT BLVD. | FREMONT | CA | 94538 |
| K023780 | MICROGENICS CORP. |
46360 FREMONT BLVD. | FREMONT | CA | 94538 |
| K970509 | OXIS INTL., INC. |
6040 NORTH CUTTER CIR., #317 | PORTLAND | OR | 97217-3935 |
| K132090 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K983555 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
BRANCHBURG TOWNSHIP | SOMERVILLE | NJ | 08876-3771 |
| K983556 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
BRANCHBURG TOWNSHIP | SOMERVILLE | NJ | 08876-3771 |
| K961726 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
1080 U.S. HIGHWAY 202 | BRANCHBURG | NJ | 08876-1760 |
| K962280 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
BRANCHBURG TOWNSHIP | SOMERVILLE | NJ | 08876-3771 |
| K033165 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K033246 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K973536 | SCHIAPPARELLI BIOSYSTEMS, INC. |
368 PASSAIC AVE. | FAIRFIELD | NJ | 07004 |
| K082030 | Siemens Healthcare Diagnostics Inc. |
PO BOX 6101 | NEWARK | DE | 19714-6101 |
| K940048 | SOLARCARE TECHNOLOGIES CORP,INC. |
1745 EATON AVE. | BETHLEHEM | PA | 18018-1799 |
| K091617 | Thermo Fisher Scientific |
7998 GEORGETOWN ROAD | INDIANAPOLIS | IN | 46268 |
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