FDA 510(k) Applications for Medical Device:
Acid, Uric, Uricase (Colorimetric)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K991247 | A.P. TOTAL CARE, INC. |
70 HAWLEY AVE, | BRIDGEPORT | CT | |
| K102568 | ABBOTT LABORATORIES |
1921 HURD DRIVE | IRVING | TX | 75038 |
| K022096 | BAYER DIAGNOSTICS CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K970919 | BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD., W-337 | BREA | CA | 92622-8000 |
| K981604 | CARESIDE, INC. |
6100 BRISTOL PKWY. | CULVER CITY | CA | 90230 |
| K971133 | CAROLINA LIQUID CHEMISTRIES CORP. |
451 WEST LAMBERT RD., | BREA | CA | 92821 |
| K031044 | CLINICAL DATA, INC. |
1075 W. LAMBERT ROAD | BREA | CA | 92821 |
| K040467 | CLINICAL DATA, INC. |
1075 W. LAMBERT ROAD | BREA | CA | 92821 |
| K970867 | DERMA MEDIA LAB., INC. |
8531 WELLSFORD PL., SUITE E | SANTA FE SPRINGS | CA | 90670 |
| K955496 | DIAGNOSTIC CHEMICALS LTD. |
WEST ROYALTY INDUSTRIAL PARK, | CHARLOTTETOWN, P.E.I. | C1E 2A6 | |
| K961586 | DIAGNOSTIC CHEMICALS LTD. |
WEST ROYALTY INDUSTRIAL PARK, | CHARLOTTETOWN, P.E.I. | C1E 2A6 | |
| K012038 | JAS Diagnostics, Inc. |
7220 NW 58TH ST. | MIAMI | FL | 33166 |
| K062862 | OLYMPUS AMERICA, INC. |
3131 WEST ROYAL LN. | IRVING | TX | 75063-3104 |
| K970560 | POINTE SCIENTIFIC, INC. |
1025 JOHN A. PAPALAS DR. | LINCOLN PARK | MI | 48146 |
| K993469 | WAKO CHEMICALS, USA, INC. |
1600 BELLWOOD ROAD | RICHMOND | VA | 23237 |
| K023550 | WIENER LABORATORIES S.A.I.C. |
2944 RIOBAMBA | ROSARIO, SANTA FE | 2000 | |
| K010421 | WIENER LABORATORIES S.A.I.C. |
2944 RIOBAMBA | ROSARIO | 2000 |
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