FDA 510(k) Applications for Medical Device:
Antigens, All Types, Escherichia Coli
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K980507 | ALEXON - TREND, INC. |
14000 UNITY ST., N.W. | RAMSEY | MN | 55303-9115 |
| K972156 | GUARDIAN SCIENTIFIC, CORP. |
8990-E ROUTE 108 | COLUMBIA | MD | 21045 |
| K061889 | INVERNESS MEDICAL-BIOSTAR INC. |
331 SOUTH 104TH ST. | LOUISVILLE | CO | 80516 |
| K222829 | Meridian Bioscience Inc. |
3471 River Hills Drive | Cincinnati | OH | 45244 |
| K023599 | MERIDIAN BIOSCIENCE, INC. |
3471 RIVER HILLS DR. | CINCINNATI | OH | 45244 |
| K062546 | MERIDIAN BIOSCIENCE, INC. |
3471 RIVER HILLS DR. | CINCINNATI | OH | 45244 |
| K990263 | MERIDIAN DIAGNOSTICS, INC. |
3471 RIVER HILLS DR. | CINCINNATI | OH | 45244 |
| K971663 | MUREX BIOTECH LTD. |
CENTRAL RD., TEMPLE HILL | DARTFORD,KENT | DA1 5LR | |
| K973457 | SHARED SYSTEMS, INC. |
3961 COLUMBIA RD. | MARTINEZ | GA | 30907 |
| K121411 | TECHLAB INC., CORPORATE RESEARCH CENTER |
2001 KRAFT DR. | BLACKSBURG | VA | 24060-6358 |
| K121364 | TECHLAB INC., CORPORATE RESEARCH CENTER |
2001 KRAFT DR. | BLACKSBURG | VA | 24060-6358 |
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