FDA 510(k) Applications for Medical Device:
Culture Media, Non-Propagating Transport
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K232454 | ALB Luz |
Rua Um, 437 | Valinhos | 13273-200 | |
| K231843 | ARX Sciences, Inc. |
160 Lawrence Bell Drive | Amherst | NY | 14221 |
| K202531 | Azer Scientific, Inc. |
701 Hemlock Road | Morgantown | PA | 19543 |
| K024240 | BD |
1 BECTON DR. | FRANKLIN LAKES | NJ | 07417 |
| K211707 | BioTeke Corporation (WuXi) Co., Ltd |
4th Floor, D5, No. 1719, Huishan Avenue | Wuxi City | 21474 | |
| K042970 | COPAN DIAGNOSTICS, INC. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K001780 | COPAN DIAGNOSTICS, INC. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K142094 | COPAN ITALIA S.P.A. |
62 FOREST STREE, SUITE 300 | MARLBOROUGH | MA | 01752 |
| K220052 | Copan Italia S.p.A. |
via F. Perotti 10 | Brescia | 25125 | |
| K232357 | Copan Italia S.p.A. |
via Francesco Perotti 10 | Brescia | 25125 | |
| K232565 | Copan Italia S.p.A. |
via Francesco Perotti 10 | Brescia | 25125 | |
| K180052 | Copan Italia S.p.A. |
Via F. Perotti 10 | Brescia | 25125 | |
| K220908 | Ensol Biosciences Inc. |
51, Techno 10-ro, Yuseong-gu | Daejeon | 34036 | |
| K163436 | GREINER BIO-ONE NA INC. |
4238 CAPITAL DRIVE | MONROE | NC | 28110 |
| K233449 | Hanchang Medic Co., Ltd. (Han Chang Medic) |
10, Wolsan-ro 201beon-gil, Eumbong-myeon | Asan-Si | 14501 | |
| K242576 | Hangzhou Alltest Biotech Co.,Ltd |
#550, Yinhai Street | Hangzhou | 310018 | |
| K231027 | Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. |
#139 10th Street (East) | Hangzhou | 310018 | |
| K955451 | HARDY DIAGNOSTICS |
1430 WEST MCCOY LN. | SANTA MARIA | CA | 93455 |
| K993812 | HARDY DIAGNOSTICS |
1430 WEST MCCOY LN. | SANTA MARIA | CA | 93455 |
| K233534 | Hardy Diagnostics |
1430 West McCoy Lane | Santa Maria | CA | 93455 |
| K212856 | Huachenyang (Shenzhen) Technology Co. Ltd. |
F8/Bldg 4, Hengchangrong High Industrial Park, | Shenzhen | 518103 | |
| K141506 | MEDICAL CHEMICAL CORPORATION |
19430 VAN NESS AVE | TORRANCE | CA | 90501 |
| K150887 | MEDICAL CHEMICAL CORPORATION |
19430 VAN NESS AVE | TORRANCE | CA | 90501-1104 |
| K964637 | MEDICAL PACKAGING CORP. |
941 AVENIDA ACASO | CAMARILLO | CA | 93012-8700 |
| K970597 | MEDICAL PACKAGING CORP. |
941 AVENIDA ACASO | CAMARILLO | CA | 93012-8700 |
| K972726 | MEDICAL PACKAGING CORP. |
941 AVENIDA ACASO | CAMARILLO | CA | 93012-8700 |
| K212743 | MedSchenker, Inc. |
10 Industrial Ave, Suite 4 | Mahwah | NJ | 07430 |
| K201674 | Merit Medical Systems, Inc |
1600 West Merit Parkway | South Jordan | UT | 84095 |
| K162284 | PURITAN MEDICAL PRODUCTS LLC |
31 SCHOOL STREET | GUILFORD | ME | 04443 |
| K160082 | PURITAN MEDICAL PRODUCTS LLC |
31 SCHOOL STREET | GUILFORD | ME | 04443-0149 |
| K142366 | PURITAN MEDICAL PRODUCTS LLC |
31 SCHOOL STREET | GUILFORD | ME | 04443 |
| K113249 | PURITAN MEDICAL PRODUCTS LLC |
31 SCHOOL STREET | GUILFORD | ME | 04443 |
| K965149 | REMEL CO. |
12076 SANTA FE DR. | LENEXA | KS | 66215 |
| K965152 | REMEL CO. |
12076 SANTA FE DR. | LENEXA | KS | 66215 |
| K965151 | REMEL CO. |
12076 SANTA FE DR. | LENEXA | KS | 66215 |
| K965150 | REMEL CO. |
12076 SANTA FE DR. | LENEXA | KS | 66215 |
| K961046 | REMEL, L.P. |
12076 SANTA FE DR. | LENEXA | KS | 66215 |
| K024237 | SARSTEDT, INC. |
1025 ST. JAMES CHURCH RD. | NEWTON | NC | 28658 |
| K230035 | Shenzhen Dakewe Bio-engineering Co., Ltd. |
Room 702-703, Building No.1,Shenzhen Biomedicine Innovations | Shenzhen | 518122 | |
| K240235 | Shenzhen Dakewe Bio-engineering Co., Ltd. |
Rm 702-703, Bldg No.1, Shenzhen Biomedicine Innovations | Shenzhen | 518122 | |
| K032246 | STARPLEX SCIENTIFIC, INC. |
50 STEINWAY BLVD. | ETOBICOKE, ONTARIO | M9W 6Y3 | |
| K962843 | STARPLEX SCIENTIFIC, INC. |
50-B STEINWAY BLVD. | ETOBICOKE, ONTARIO | M9W 6Y3 | |
| K211256 | Wuxi Nest Biotechnology Co., Ltd. |
No.530 Xida Road, New District | Wuxi | 214112 | |
| K220739 | Zhejiang Gongdong Medical Technology Co., Ltd. |
No. 10 Beiyuan Ave., Huangyan | Taizhou | 318020 |
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