FDA 510(k) Applications for Medical Device:
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K092767 | BECTON DICKINSON & CO. |
7 LOVETON CIR. | SPARKS | MD | 21152 |
| K042812 | BECTON DICKINSON & CO. |
7 LOVETON CIR. | SPARKS | MD | 21152 |
| K100589 | BIO-RAD |
180 Cabot Street | Beverly | MA | 01915 |
| K070361 | BIO-RAD |
163 CABOT ST. | BEVERLY | MA | 01915 |
| K081212 | BIO-RAD |
163 CABOT ST. | BEVERLY | MA | 01915 |
| K171061 | Bio-Rad |
3 Boulevard Raymond Poincare | 92430 Marnes-la-Coquette | 92430 | |
| K103684 | BIO-RAD |
180 Cabot Street | Beverly | MA | 01915 |
| K122187 | BIO-RAD |
180 Cabot Street | Beverly | MA | 01915 |
| K181092 | bioMerieux SA |
376 Chemin de l'Orme | Marcy l'Etoile | 69280 | |
| K151688 | bioMerieux, Inc. |
595 Anglum Rd. | Hazelwood | MO | 63042 |
| K162076 | bioMerieux, Inc. |
595 Anglum Road | Hazelwood | MO | 63042 |
| K091024 | BIOMERIEUX, INC. |
595 ANGLUM RD. | HAZELWOOD | MO | 63042 |
| K091025 | BIOMERIEUX, INC. |
595 ANGLUM RD. | HAZELWOOD | MO | 63042 |
| K952595 | CLINICAL STANDARDS LABORATORIES, INC. |
2011 EAST UNIVERSITY DR. | RANCHO DOMINGUEZ | CA | 90220-6445 |
| K964560 | HARDY DIAGNOSTICS |
1430 WEST MCCOY LN. | SANTA MARIA | CA | 93455 |
| K190553 | Hardy Diagnostics |
1430 West McCoy Lane | Santa Maria | CA | 93455 |
| K160512 | HARDY DIAGNOSTICS |
1430 WEST MCCOU LANE | SANTA MARIA | CA | 93455 |
| K102922 | HARDY DIAGNOSTICS |
1430 WEST MCCOY LN. | SANTA MARIA | CA | 93455 |
| K962744 | PREPARED MEDIA LABORATORY, INC. |
15845 SW 72ND AVE. | PORTLAND | OR | 97224 |
| K162620 | REMEL, INC. |
12076 SANTA FE DRIVE | LENEXA | KS | 66215 |
| K092407 | REMEL, INC. |
12076 SANTA FE DR. | LENEXA | KS | 66215 |
| K972359 | REMEL, L.P. |
12076 SANTA FE DR. | LENEXA | KS | 66215-3594 |
| K092819 | Thermo Fisher Scientific |
12150 SANTA FE DRIVE | LENEXA | KS | 66215 |
| K073027 | Thermo Fisher Scientific |
12150 SANTA FE DRIVE | LENEXA | KS | 66215 |
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