FDA 510(k) Applications for Medical Device:
Test, Urea (Breath Or Blood)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K973000 | ALIMENTERICS, INC. |
301 AMERICAN RD. | MORRIS PLAINS | NJ | 07950 |
| K173777 | Exalenz Bioscience Ltd. |
4 Ha'Maayan st. | Modiin | 7177872 | |
| K162150 | Exalenz Bioscience Ltd. |
4 Ha'Maayan Street | Modiin | 7177872 | |
| K130524 | EXALENZ BIOSCIENCE LTD. |
11925 W I-70 FRONTAGE RD NORTH | WHEAT RIDGE | CO | 80033 |
| K173772 | Exalenz Bioscience Ltd. |
4 Ha'Maayan st. | Modiin | 7177872 | |
| K193610 | Exalenz Bioscience Ltd. |
4 Ha'Maayan st. | Modiin | 7177872 | |
| K093834 | HEMA METRICS, LLC |
136 W. 2ND ST. | OGDEN | UT | 84404 |
| K000316 | MERETEK |
618 GRASSMERE PARK DR. | NASHVILLE | TN | 37211 |
| K014225 | MERETEK DIAGNOSTICS, INC. |
618 GRASSMERE PARK DRIVE, | NASHVILLE | TN | 37211 |
| K972352 | MERETEK DIAGNOSTICS, INC. |
618 GRASSMERE PARK DRIVE, | NASHVILLE | TN | 37211 |
| K220494 | Meridian Bioscience Israel Ltd. |
4 Ha'Maayan st, | Modiin | 7177872 | |
| K221896 | Meridian Bioscience Israel Ltd. |
4 Ha'Maayan St | Modiin | 7177872 | |
| K223185 | Meridian Bioscience Israel Ltd. |
4 Ha'Maayan St | Modiin | 7177872 | |
| K990931 | METABOLIC SOLUTIONS, INC. |
460 AMHERST ST. | NASHUA | NH | 03063-1220 |
| K011668 | ORIDION MEDICAL 1987 LTD. |
7 HAMARPE ST. P.O. BOX 45025 | JERUSALEM | 91450 | |
| K092817 | OTSUKA PHARMACEUTICAL CO., LTD. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K041148 | OTSUKA PHARMACEUTICAL CO., LTD. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
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