The following data is part of a premarket notification filed by Cepheid with the FDA for Smart Gbs And Smartcycle Dx System And Software, Version 1.7b.
| Device ID | K062948 |
| 510k Number | K062948 |
| Device Name: | SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B |
| Classification | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| Applicant | CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189 |
| Contact | Russel K Enns |
| Correspondent | Russel K Enns CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189 |
| Product Code | NJR |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-28 |
| Decision Date | 2006-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332940004910 | K062948 | 000 |
| 07332940004538 | K062948 | 000 |
| 07332940004545 | K062948 | 000 |
| 07332940004569 | K062948 | 000 |
| 07332940004583 | K062948 | 000 |
| 07332940004606 | K062948 | 000 |
| 07332940004743 | K062948 | 000 |
| 07332940004767 | K062948 | 000 |
| 07332940004798 | K062948 | 000 |
| 07332940004804 | K062948 | 000 |
| 07332940004835 | K062948 | 000 |
| 07332940004842 | K062948 | 000 |
| 07332940004866 | K062948 | 000 |
| 07332940004880 | K062948 | 000 |
| 07332940004903 | K062948 | 000 |
| 07332940004521 | K062948 | 000 |