FDA 510(k) Applications for Medical Device:
Labware, Assisted Reproduction

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K993881 INTL., INC. 170 FORT PATH RD.
MADISON CT 06443
K080395 INTL., INC. 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
K233177 Cook Incorporated 750 Daniels Way
Bloomington IN 47404
K092398 CRYO BIO SYSTEM 26552 TAMPICO PLACE
MISSION VIEJO CA 92691
K232980 CytoSwim Ltd Unit 34, The Venture Centre,
Coventry CV4 7EZ
K173075 DxNow, Inc. 401 Professional Drive, Suite 130
Gaithersburg MD 20879-3429
K241341 FUJIFILM Irvine Scientific 2511 Daimler Street
Santa Ana CA 92705
K994361 GENESIS INDUSTRIES, INC. 303 S. MCKAY AVE.
SPRING VALLEY WI 54767
K240002 Gimbo Medical Technology Shenzhen Co., Ltd. 601, Building C5, No. 459 Qiaokai Road, Fenghuang Street,
Shenzhen 518107
K241454 Guangzhou Hehong Biotech Co., Ltd. A zone, 2/F, Building A, Huazi Industrial Park,
Guangzhou 511447
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
K241626 iPreg Incorporation 4F-3., No. 77, Sec. 1, Xintai 5th Rd., Xizhi Dist.
New Taipei City 221
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
K241348 MotilityCount ApS Gl. K°ge Landevej 57, 2.
Valby DK-2500
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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