FDA 510(k) Applications for Medical Device:
Lancet, Blood
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K223352 | Accriva Diagnostics, Inc. |
6260 Sequence Drive | San Diego | CA | 92121 |
| K113332 | ACON LABORATORIES, INC. |
10125 MESA RIM ROAD | SAN DIEGO | CA | 92121 |
| K222084 | Asahi Polyslider Co., Ltd. |
860-2 Misaki | Maniwa | 719-3226 | |
| K223243 | Becton, Dickinson and Company |
1 Becton Drive | Franklin Lakes | NJ | 07417 |
| K222408 | Beijing Ruicheng Medical Supplies Co., Ltd. |
No.13 Yanqi Ave, Yanqi Economic Development Zone, | Beijing | 101400 | |
| K223900 | Clinical Innovations, LLC |
747 West 4170 South | Murray | UT | 84123 |
| K223826 | Drawbridge Health, Inc. |
620 Omni Industrial Blvd. | Summerville | FL | 29486 |
| K223370 | Facet Technologies LLC |
3900 North Commerce Drive | Atlanta | GA | 30344 |
| K153670 | Genteel, LLC |
4011 Livingstone St. | Midland | TX | 79707 |
| K172712 | GRI Medical & Electronic Technology Co, Ltd |
XiuZhou Industry Zone, 1805 Honggao Road | JiaXing | 314031 | |
| K220917 | GRI-Alleset, Inc. |
4142 Industry Way | Flowery Branch | GA | 314031 |
| K242664 | GRI-Alleset, Inc. |
4142 Industry Way | Flowery Branch | GA | 30542 |
| K221839 | Hebei Xinle Sci&Tech Co., Ltd |
No.2, Xingye Street, Xinle City | Shijiazhuang | 050700 | |
| K243533 | HLB Co., Ltd. Healthcare |
10-5, Myeonghaksandanseo-ro, Yeondong-myeon | Sejong-si | 30068 | |
| K220643 | HTL-Strefa S.A. |
Adamowek 7 | Ozorkow | 95-035 | |
| K223313 | HUAIAN HENING MEDICAL INSTRUMENTS CO., LTD |
No. 6 West Hongdou Road Economic Development Zone | Huaian | ||
| K001162 | MALI-TECH LTD. |
POB 454 | GINOT SHOMRON | 44853 | |
| K241750 | Medifun Corporation |
4F-1, 4F-9, 4F-10, No.99, Jingke S. Rd., Nantun Dist., | Taichung City | 408 | |
| K130132 | MEDIPURPOSE PTE. LTD. |
111 LAUREL RIDGE DRIVE | ALPHARETTA | GA | 30004 |
| K101417 | MEDIPURPOSE PTE. LTD. |
111 LAUREL RIDGE DRIVE | ALPHARETTA | GA | 30004 |
| K101145 | MEDIPURPOSE PTE. LTD. |
111 LAUREL RIDGE DRIVE | ALPHARETTA | GA | 30004 |
| K222224 | MediPurpose Pte. Ltd. |
10 Anson Road, No. 12-08 International Plaza | Singapore | 079903 | |
| K113513 | MICROPOINT TECHNOLOGIES PTE LTD |
11, KALLANG PLACE | SINGAPORE | 339155 | |
| K241848 | Ningbo Caremed Medical Products Co. Ltd. |
No.79 Jiutang Road, South Side Hangzhou Bay New Zone | Ningbo | 315336 | |
| K242316 | Ningbo Medsun Medical Co., Ltd. |
No. 298 Huangjipu Road, Jiangbei | Ningbo | 315031 | |
| K242627 | Ningbo Medsun Medical Co., Ltd. |
No. 298 Huangjipu Road, Jiangbei | Ningbo | 315031 | |
| K222090 | Ningbo Medsun Medical Co., Ltd. |
No.55 Jinxi Road, Zhenhai | Ningbo | 315221 | |
| K221783 | NSP Tech Pte Ltd |
10 Admiralty Street, Northlink Building, #02-06 | Singapore | 757695 | |
| K221604 | NSP Tech Pte Ltd |
10 Admiralty Street, #02-06 Northlink Building | Singapore | 757695 | |
| K222168 | Owen Mumford Ltd |
Brook Hill | Woodstock | OX20 1TU | |
| K222111 | Owen Mumford Ltd |
Brook Hill | Woodstock | OX20 1TU | |
| K231124 | Owen Mumford Ltd |
Brook Hill | Woodstock | OX20 1TU | |
| K221126 | Owen Mumford Ltd |
Brook Hill | Woodstock | OX20 1TU | |
| K222303 | Owen Mumford Ltd |
Owen Mumford, Brook Hill, Woodstock | Woodstock | OX20 ITU | |
| K024170 | PELIKAN TECHNOLOGIES, INC |
1072 EAST MEADOW CIRCLE | PALO ALTO | CA | 94303 |
| K041665 | PELIKAN TECHNOLOGIES, INC |
1072 EAST MEADOW CIRCLE | PALO ALTO | CA | 94303 |
| K242680 | PrivaPath Diagnostics Ltd (dba LetsGetChecked) |
Unit 1, Northern Cross Business Park | Dublin | D11XT26 | |
| K221368 | Promisemed Hangzhou Meditech Co., Ltd. |
No. 1388 Cangxing Street, Cangqian Community,Yuhang District | Hangzhou City | 311121 | |
| K192666 | Promisemed Hangzhou Meditech Co., Ltd. |
No. 12, Longtan Road, Cangqian Street | Hangzhou City | 311121 | |
| K193009 | Promisemed Hangzhou Meditech Co., Ltd. |
No. 12, Longtan Road, Cangqian Street | Hangzhou City | 311121 | |
| K221371 | Promisemed Hangzhou Meditech Co., Ltd. |
No. 1388 Cangxing Street, Cangqian Community,Yuhang District | Hangzhou City | 311121 | |
| K234081 | RedDrop Dx |
2401 Research Blvd, #206 | Fort Collins | CO | 80526 |
| K232488 | Roche Diabetes Care, Inc. |
9115 Hague Road | Indianapolis | IN | 46250 |
| K220849 | Roche Diabetes Care, Inc. |
9115 Hague Road | Indianapolis | IN | 46256 |
| K220364 | Roche Diabetes Care, Inc. |
9115 Hague Road | Indianapolis | IN | 46250 |
| K232509 | Roche Diabetes Care, Inc. |
9115 Hague Road | Indianapolis | IN | 46250 |
| K222801 | Sarstedt AG & CO KG |
Sarstedtstrasse 1 | Nuembrecht | 51588 | |
| K222376 | Shandong Lianfa Medical Plastic Products Co. Ltd. |
No. 1 Shuangshan Sanjian Road, Zhangqiu | Jinan | 250200 | |
| K221521 | SteriLance Medical (Suzhou) Inc. |
No.168 PuTuoShan Road, New District, | Suzhou | 215153 | |
| K233796 | SteriLance Medical (Suzhou) Inc. |
No.168 PuTuoShan Road | Suzhou | 215153 | |
| K210745 | SteriLance Medical (Suzhou) Inc. |
No.168 PuTuoShan Road, New District | Suzhou | 215153 | |
| K244036 | SteriLance Medical (Suzhou) Inc. |
No.168 PuTuoShan Road, New District | Suzhou | 215153 | |
| K221778 | Suzhou Kyuan Medical Apparatus Co., Ltd. |
Beiqiao Town, Suzhou City, P.R.China | Suzhou | ||
| K223208 | Suzhou Zhenwu Medical Co., Ltd. |
No. 248, Chijiawan Road, Wujiang District, Suzhou City, | Suzhou | 215214 | |
| K221131 | Tasso, Inc. |
1631 15th Ave W, Suite 105 | Seattle | WA | 98119 |
| K220372 | Tianjin Huahong Technology Co., Ltd. |
A01, Plant B, No. 278, Hangkong Road, Tianjin Pilot Free | Tianjin | 300308 | |
| K251694 | Tianjin Huahong Technology Co., Ltd. |
A01, Plant B, No. 278 Hangkong Road | Tianjin | 300308 | |
| K220370 | Tianjin Huahong Technology Co., Ltd. |
A01, Plant B, No. 278, Hangkong Road, Tianjin Pilot Free | Tianjin | 300308 | |
| K240806 | Tianjin Huahong Technology Co., Ltd. |
A01, Plant B, No. 278, Hangkong Road, | Tianjin | 300308 | |
| K241627 | Tianjin Huahong Technology Co., Ltd. |
A01, Plant B, No. 278, Hangkong Road, Tianjin Pilot Free | Tianjin | 300308 | |
| K222055 | Tianjin Rilifine Medical Device Co., Ltd. |
No 32, Jingguan Road, Yixingbu, Beichen District | Tianjin | 300402 | |
| K223201 | YourBio Health, Inc. |
200 Boston Avenue | Medford | MA | 02155 |
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