FDA 510(k) Applications for Medical Device:
Kinetic Method, Gamma-Glutamyl Transpeptidase
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K955770 | ABAXIS, INC. |
1320 CHESAPEAKE TERRACE | SUNNYVALE | CA | 94089 |
| K971466 | CAROLINA LIQUID CHEMISTRIES CORP. |
451 WEST LAMBERT RD., | BREA | CA | 92821 |
| K964916 | DERMA MEDIA LAB., INC. |
8531 WELLSFORD PL., SUITE E | SANTA FE SPRINGS | CA | 90670 |
| K974000 | DIAGNOSTIC CHEMICALS LTD. |
WEST ROYALTY INDUSTRIAL PARK, | CHARLOTTETOWN, P.E.I. | C1E 2A6 | |
| K973157 | POINTE SCIENTIFIC, INC. |
1025 JOHN A. PAPALAS DR. | LINCOLN PARK | MI | 48146 |
| K964457 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
1080 U.S. HIGHWAY 202 | BRANCHBURG | NJ | 08876-1760 |
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