FDA 510(k) Applications for Medical Device:
Enzyme Immunoassay, Tracrolimus
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K060502 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K060385 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714 |
| K070820 | FUJIREBIO DIAGNOSTICS, INC. |
201 GREAT VALLEY PKWY. | MALVERN | PA | 19355-1307 |
| K050206 | MICROGENICS CORP. |
46360 FREMONT BLVD. | FREMONT | CA | 94538 |
| K123343 | MICROGENICS CORP. |
46360 FREMONT BLVD | FREMONT | CA | 94538 |
| K173857 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K203833 | Shanghai Genext Medical Technology Co., Ltd. |
Rm1101, 11th Floor, Bldg 2, Pujiang Hi-Tech Plaza, No.2388 | Shanghai | 201114 | |
| K150168 | SIEMENS HEALTHCARE DIAGNOSTICS |
500 GBC DRIVE | NEWARK | DE | 19714 |
| K063868 | WATERS CORPORATION |
163 CABOT STREET | BEVERLY | MA | 01915 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
