The following data is part of a premarket notification filed by Diasorin Molecular Llc with the FDA for Simplexa Gbs Direct, Simplexa Gbs Positive Control Pack.
| Device ID | K182467 |
| 510k Number | K182467 |
| Device Name: | Simplexa GBS Direct, Simplexa GBS Positive Control Pack |
| Classification | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| Applicant | DiaSorin Molecular LLC 11331 Valley View Street Cypress, CA 90630 |
| Contact | Sharon Young |
| Correspondent | Sharon Young DiaSorin Molecular LLC 11331 Valley View Street Cypress, CA 90630 |
| Product Code | NJR |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-10 |
| Decision Date | 2018-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20816101025651 | K182467 | 000 |
| 20816101025644 | K182467 | 000 |