FDA 510(k) Applications for Medical Device:
Nitroprusside, Ketones (Urinary, Non-Quant.)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K060768 | ABBOTT DIABETES CARE INC. |
1360 SOUTH LOOP RD. | ALAMEDA | CA | 94502 |
| K170587 | ACON Laboratories, Inc. |
10125 Mesa Rim Road | San Diego | CA | 92121 |
| K182593 | Apex Biotechnology Corp. |
No. 7, Li-Hsin Road V, Hsinchu Science Park | Hsinchu | 30078 | |
| K170463 | i-SENS, Inc. |
43,Banpo-daero 28-gil | Seoul | 06646 | |
| K201551 | i-SENS, Inc. |
43, Banpo-daero 28-gil, Seocho-gu | Seoul | 06646 | |
| K033114 | NEO DIAGNOSTICS, INC |
10532 WALKER ST. | CYPRESS | CA | 90630 |
| K953680 | POLYMER TECHNOLOGY INTL. |
1871 N.W. GILMAN BLVD. | ISSAQUAH | WA | 98027 |
| K953662 | POLYMER TECHNOLOGY INTL. |
1871 N.W. GILMAN BLVD. | ISSAQUAH | WA | 98027 |
| K173345 | TaiDoc Technology Corporation |
B1-7F, No. 127, Wugong 2nd Rd., Wugu District | New Taipei City | 24888 | |
| K003987 | TECO DIAGNOSTICS |
4925 EAST HUNTER AVE. | ANAHEIM | CA | 92807 |
| K192957 | Vivachek Biotech (Hangzhou) Co., Ltd |
1/2/3 F, Building 1, 16 East Zhenxing Rd., Yuhang | Hangzhou | 311100 |
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