FDA 510(k) Applications for Medical Device:
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K093879 | ACON LABORATORIES, INC. |
10125 MESA RIM RD. | SAN DIEGO | CA | 92121 |
| K023184 | BAYER DIAGNOSTICS CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K972011 | BEHRING DIAGNOSTICS, INC. |
151 UNIVERSITY AVE. | WESTWOOD | MA | 02090 |
| K121247 | CHEMATICS, INC. |
P.O. BOX 293 | NORTH WEBSTER | IN | 46555 |
| K121256 | CHEMATICS, INC. |
P.O. BOX 293 | NORTH WEBSTER | IN | 46555 |
| K061792 | DADE BEHRING, INC. |
P.O. BOX 6101 BLDG 500;M.S.514 | NEWARK | DE | 19714-6101 |
| K070853 | DADE BEHRING, INC. |
P.O. Box 6101, M/S 514 | Newark | DE | 19714-6101 |
| K071811 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY; | NEWARK | DE | 19714-6101 |
| K955633 | DIAGNOSTIC CHEMICALS LTD. |
WEST ROYALTY INDUSTRIAL PARK, | CHARLOTTETOWN, P.E.I. | C1E 2A6 | |
| K993920 | DIAGNOSTIC CHEMICALS LTD. |
16 MCCARVILLE ST. | CHARLOTTETOWN | C1E 2A6 | |
| K001286 | DIAGNOSTIC CHEMICALS LTD. |
16 MCCARVILLE ST. | CHARLOTTETOWN | C1E 2A6 | |
| K974002 | DIAGNOSTIC CHEMICALS LTD. |
WEST ROYALTY INDUSTRIAL PARK, | CHARLOTTETOWN, P.E.I. | C1E 2A6 | |
| K181553 | Immunalysis Corporation |
829 Towne Center Drive | Pomona | CA | 91767 |
| K032461 | Lin-Zhi International, Inc. |
687 NORTH PASTORIA AVE. | SUNNYVALE | CA | 94085-2917 |
| K111005 | MEDICA CORP. |
5 OAK PARK DRIVE | BEDFORD | MA | 01730 |
| K972725 | POINTE SCIENTIFIC, INC. |
1025 JOHN A. PAPALAS DR. | LINCOLN PARK | MI | 48146 |
| K092273 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K010960 | SYVA CO., DADE BEHRING, INC. |
P.O. BOX 49013 | SAN JOSE | CA | 95135 |
| K111206 | TECO DIAGNOSTICS |
1268 NORTH LAKEVIEW AVE. | ANAHEIM | CA | 92807 |
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