FDA 510(k) Applications for Medical Device:
Labware, Assisted Reproduction
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K993881 |
170 FORT PATH RD. | MADISON | CT | 06443 | |
| K080395 |
393 SOUNDVIEW RD. | GUILFORD | CT | 06437 | |
| K203626 | Allwin Medical Devices, Inc |
3305 E. Miraloma Avenue, Suite 176 | Anaheim | CA | 92806 |
| K141663 | AUXOGYN, INC. |
1490 O'BRIEN DRIVE, SUITE A | MENLO PARK | CA | 94025 |
| K103028 | AUXOGYN, INC. |
1490 O'BRIEN DRIVE | MENLO PARK | CA | 94545 |
| K991249 | BECTON DICKINSON LABWARE |
1 BECTON DR. | FRANKLIN LAKES | NJ | 07465-1886 |
| K991251 | BECTON DICKINSON LABWARE |
1 BECTON DR. | FRANKLIN LAKES | NJ | 07465-1886 |
| K991253 | BECTON DICKINSON LABWARE |
1 BECTON DR. | FRANKLIN LAKES | NJ | 07465-1886 |
| K052457 | BIOCOAT, INC. |
211 WITMER RD. | HORSHAM | PA | 19044 |
| K081896 | BIOGENICS, INC. |
2797 NAPA VALLEY CORPORATE DR. | NAPA | CA | 94558 |
| K122982 | BIOTECH, INC. |
3722 AVE. SAUSALITO | IRVINE | CA | 92606 |
| K221810 | Bonraybio Co., LTD. |
4F., No. 118, Gongye 9th Rd., Dali Dist. | Taichung City | 41280 | |
| K092398 | CRYO BIO SYSTEM |
26552 TAMPICO PLACE | MISSION VIEJO | CA | 92691 |
| K173075 | DxNow, Inc. |
401 Professional Drive, Suite 130 | Gaithersburg | MD | 20879-3429 |
| K994361 | GENESIS INDUSTRIES, INC. |
303 S. MCKAY AVE. | SPRING VALLEY | WI | 54767 |
| K123641 | HERTART |
KORSKILDELUND 6 | GREVE | 2670 | |
| K150756 | HERTART |
Gustaf Werners gata 2 | V. Frolunda | SE-421 32 | |
| K201213 | HertART Aps |
Gustaf Werners gata 2 | Vastra Frolunda | SE-421 32 | |
| K990941 | HUMAGEN FERTILITY DIAGNOSTICS, INC. |
2400 HUNTER'S WAY | CHARLOTTESVILLE | VA | 22911 |
| K000915 | HUMAGEN FERTILITY DIAGNOSTICS, INC. |
2400 HUNTER'S WAY | CHARLOTTESVILLE | VA | 22911 |
| K112695 | KITAZATO BIOPHARMA CO;LTD |
611 WEST 5TH ST | AUSTIN | TX | 78701 |
| K153027 | KITAZATO BIOPHARMA CO., LTD. |
81 Nakajima | FUJI | 416-0907 | |
| K140072 | KITAZATO BIOPHARMA CO., LTD. |
816 CONGRESS AVE SUITE 1400 | AUSTIN | TX | 78701 |
| K181469 | Kitazato Corporation |
81 Nakajima | Fuji | 416-0907 | |
| K112644 | LOTUS BIO LTD |
461 MAIN STREET | PAWTUCKET | RI | 02860 |
| K133295 | MENICON CO., LTD. NEW BUSINESS DIVISION |
4050 OLSON MEMORIAL HWY, SUITE 450 | MINNEAPOLIS | MN | 55422 |
| K100596 | MID-ATLANTIC DIAGNOSTICS, INC. |
18905 CELEBRITY LANE | SANDY SPRING | MD | 20860 |
| K131145 | NIDACON INTERNATIONAL AB |
8870 RAVELLO CT | NAPLES | FL | 34114 |
| K070047 | NUNC A/S |
KAMSTRUPUEJ 90, KAMSTRUP | ROSKILDE | DK-4000 | |
| K040717 | NUNC A/S |
KAMSTRUPUEJ 90, KAMSTRUP | ROSKILDE | DK-4000 | |
| K162833 | ORIGIO A/S |
KNARDRUPVEJ 2 | MALOV | 2760 | |
| K180740 | ORIGIO a/s |
Knardrupvej 2 | Malov | 2760 | |
| K200815 | ORIGIO a/s |
Knardrupvej 2 | Malov | 2760 | |
| K162640 | REPROBITECH CORP. |
27 HADDON RD | New Hyde Park | NY | 11040 |
| K172751 | Reprobitech Corp. |
42-31 Colden St., Suite 202 | Flushing | NY | 11355 |
| K162051 | REPROLIFE INC. |
2-5-5-8F, SHINJUKU | SHINJUKU-KU | 160-0022 | |
| K112413 | RESEARCH INSTRUMENTS LTD. |
BICKLAND INDUSTRIAL PARK | FALMOUTH, CORNWALL | TR11 4TA | |
| K090429 | THERMO FISHER SCIENTIFIC (NALGE NUNC INTL) |
75 PANORAMA CREEK DRIVE | ROCHESTER | NY | 14625-2385 |
| K150961 | VITROLIFE A/S |
JENS JUULS VEJ 20 | VIBY J | DK-8260 | |
| K213869 | Vitrolife A/S |
Jens Juuls Vej 20 | Viby J | 8260 | |
| K090832 | VITROLIFE SWEDEN AB |
BOX 9080 | SE-400 92 GOTEBORG | ||
| K140207 | VITROLIFE SWEDEN AB |
1111 PENNSYLVANIA AVENUE,NW | WASHINGTON | DC | 20004 |
| K181461 | Vitrolife Sweden AB |
Gustaf Werners gata 2 | Vastra Frolunda | 421 32 |
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