FDA 510(k) Applications for Medical Device:
Saccharogenic, Amylase
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K980013 | AC BIOCHEMICALS, INC. |
17955 SKY PARK CIRCLE, SUITE J | IRVINE | CA | 92614 |
| K991817 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K023396 | POINTE SCIENTIFIC, INC. |
1025 JOHN A. PAPALAS DR. | LINCOLN PARK | MI | 48146 |
| K953211 | RANDOX LABORATORIES, LTD. |
ARDMORE, DIAMOND ROAD | CRUMLIN | BT29 4QY |
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