The following data is part of a premarket notification filed by Guangzhou Improve Medical Instruments Co., Ltd. with the FDA for Improvacuter Gel & Clot Activator Tube.
| Device ID | K093910 |
| 510k Number | K093910 |
| Device Name: | IMPROVACUTER GEL & CLOT ACTIVATOR TUBE |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | GUANGZHOU IMPROVE MEDICAL INSTRUMENTS CO., LTD. SUITE D NO.19, LANE 999 ZHONGSHAN NO.2 ROAD(S) Shanghai, CN 20030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong GUANGZHOU IMPROVE MEDICAL INSTRUMENTS CO., LTD. SUITE D NO.19, LANE 999 ZHONGSHAN NO.2 ROAD(S) Shanghai, CN 20030 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-22 |
| Decision Date | 2010-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 46933395621357 | K093910 | 000 |
| 16933395621868 | K093910 | 000 |
| 06974481831436 | K093910 | 000 |
| 06974481831429 | K093910 | 000 |
| 06974481831399 | K093910 | 000 |
| 06974481831382 | K093910 | 000 |
| 06974481831498 | K093910 | 000 |
| 06974481831481 | K093910 | 000 |
| 06974481831467 | K093910 | 000 |
| 46933395621241 | K093910 | 000 |
| 46933395621258 | K093910 | 000 |
| 46933395621265 | K093910 | 000 |
| 46933395621340 | K093910 | 000 |
| 46933395621333 | K093910 | 000 |
| 46933395621326 | K093910 | 000 |
| 46933395621319 | K093910 | 000 |
| 46933395621302 | K093910 | 000 |
| 46933395621296 | K093910 | 000 |
| 46933395621289 | K093910 | 000 |
| 46933395621272 | K093910 | 000 |
| 06974481831450 | K093910 | 000 |