FDA 510(k) Applications for Medical Device:
Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K963040 | BIO-RAD |
4000 ALFRED NOBEL DR. | HERCULES | CA | 94547-1803 |
| K960437 | BIO-RAD |
4000 ALFRED NOBEL DR. | HERCULES | CA | 94547-1803 |
| K943547 | ISOLAB, INC. |
DRAWER 4350 | AKRON | OH | 44321 |
| K003584 | MICROMASS, INC. |
34 MAPLE ST. | MILFORD | MA | 01757 |
| K974047 | NEOMETRICS, INC. |
104 BELLEROSE AVE. | EAST NORTHPORT | NY | 11731 |
| K021541 | PERKINELMER LIFE SCIENCES |
3985 EASTERN RD. | NORTON | OH | 44203 |
| K984463 | QUANTASE LTD. |
3 RIVERVIEW BUSINESS PARK | PERTH, SCOTLAND | PH2 8DF | |
| K000754 | QUANTASE LTD. |
3 RIVERVIEW BUSINESS PARK | PERTH, SCOTLAND | PH2 8DF | |
| K961515 | SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK | DUNDEE | DD2 1SW | |
| K982307 | WALLAC, INC. |
3985 EASTERN RD. | NORTON | OH | 44203 |
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