FDA 510(k) Applications for Medical Device:
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K994278 | BECKMAN COULTER, INC. |
7330 CARROLL RD. | SAN DIEGO | CA | 92196 |
| K964764 | BEHRING DIAGNOSTICS, INC. |
151 UNIVERSITY AVE. | WESTWOOD | MA | 02090 |
| K020625 | HELENA LABORATORIES |
1530 LINDBERGH DR. | BEAUMONT | TX | 77704 |
| K972666 | HYBRITECH, INC. |
9850 DISTRIBUTION AVE. | SAN DIEGO | CA | 92121 |
| K961573 | HYBRITECH, INC. |
P.O. BOX 269006 | SAN DIEGO | CA | 92196 |
| K200475 | Immunodiagnostic Systems Ltd. |
10 Didcot Way, Boldon Business Park | Boldon | NE35 9PD | |
| K981373 | METRA BIOSYSTEMS, INC. |
265 NORTH WHISMAN RD. | MOUNTAIN VIEW | CA | 94043-3911 |
| K043125 | ORION DIAGNOSTICA OY |
KOIVU MANKKAAN TIE 6 | ESPOO | 02200 | |
| K011113 | SEBIA |
13805 WATERLOO | CHELSEA | MI | 48118 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
