The following data is part of a premarket notification filed by Apex Bio Technology Corp with the FDA for Contrex Plus Low Control Solution.
| Device ID | K100747 |
| 510k Number | K100747 |
| Device Name: | CONTREX PLUS LOW CONTROL SOLUTION |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | APEX BIO TECHNOLOGY CORP NO. 7, LI-HSIN ROAD V HSINCHU SCIENCE PARK Hsinchu, TW 30078 |
| Contact | Thomas Y.s. Shen |
| Correspondent | Thomas Y.s. Shen APEX BIO TECHNOLOGY CORP NO. 7, LI-HSIN ROAD V HSINCHU SCIENCE PARK Hsinchu, TW 30078 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-16 |
| Decision Date | 2010-04-14 |
| Summary: | summary |